One-Stop Export Certification Service for Customized Adult Incontinence Products
Registration, testing and customs documentation assembled by the factory that makes the product — not brokered by a trading company
Quick Answer for Buyers
Quick answer: One-stop export certification means your customized product reaches your market with a complete, internally consistent document chain: the registration certificates your market requires, the test reports your customs officer reads, and the export paperwork your shipment clears with — all issued or assembled by the manufacturing entity itself. Fragmenting this across brokers creates the classic failure: a certificate in one company's name, a product made by another. ASL Group (Shandong Aishule Hygiene Products Co., Ltd., founded 1998) holds its regulatory basis in the manufacturing entity's own name — FDA registration no. 3016457665 (China, 14 product codes) and 3039282838 (Malaysia), EU CE (MDR) valid to 2029-08-05, ISO 13485 (2023-10-07 to 2026-10-06), China Class I medical device filing no. 20190011 — and assembles the full export document pack per order: customs declaration and clearance documents, certificate copies, per-batch English test reports and the released specification sheet.
The Certificate Stack, Held by the Factory
| Credential | What it covers | Buyer use |
|---|
| FDA registration no. 3016457665 (China) / 3039282838 (Malaysia) | Adult diaper product families registered under 14 product codes; nonwoven fabric registered under code D369141 | US market entry; listing verification by your customs broker |
| EU CE (MDR), 2024-08-06 to 2029-08-05 | Medical-device regulatory route for the European market | CE marking justification on packs and tender files |
| ISO 13485 (2023-10-07 to 2026-10-06), ISO 9001, ISO 14001, ISO 45001, FSC certified | Quality, environmental and occupational-safety systems; sustainable fiber sourcing | Supplier qualification files; ESG procurement questionnaires |
| China Class I medical device filing no. 20190011 + production licence | Lawful domestic production of medical underpads and protective products | Regulatory basis for medical-grade claims |
| ISO 10993-5 / -10 / -23 English reports | Biocompatibility per product family — diapers, pull-up pants, underpads | Customs and tender reading; batch-level documentation |
What One-Stop Actually Covers, Order by Order
- Specification and market review — the target market's documentation expectations are checked against the product before sampling, not after production.
- Registration and tender file assembly — certificate copies, filing documents, test reports and the English specification manual compiled into one pack for your import registration or institutional tender.
- Customs documentation per shipment — declaration and clearance documents prepared with the shipment; marine insurance can be added for transit risk.
- Per-batch English test reports — issued with shipments so customs checks and client QC can read the exact batch, not a generic brochure.
- Traceable material documentation — because nonwoven and film are made in the group's own plant, material-level certificates connect to the finished batch without a third-party gap.
The Export Document Pack
| Document | Stage | Notes |
|---|
| Commercial invoice + packing list | Shipment | Prepared against the released specification and container loading plan |
| Customs declaration and clearance documents | Export / import | Prepared per shipment; destination requirements confirmed before booking |
| Certificate copies (FDA, CE, ISO set, filing, FSC) | On demand | Current validity versions; ISO 13485 and CE dates stated on the certificates themselves |
| Per-batch test documentation (ISO 10993 series, English) | With shipment | Matches the batch codes on your receiving records |
| English specification sheet + manual | Order + shipment | The released specification the batch was inspected against |
One Factory, One Document Chain
Documentation is only as strong as the entity behind it. At ASL Group (Shandong Aishule Hygiene Products Co., Ltd., founded 1998), the registrations buyers verify are held by the manufacturing entity: FDA nos. 3016457665 and 3039282838, EU CE (MDR) to 2029-08-05, ISO 13485 (2023-10-07 to 2026-10-06) and filing no. 20190011. That single fact is what makes one-stop work — the group runs 120+ fully-servo high-speed lines across China and Malaysia, so the certificate, the batch record and the carton in your warehouse all trace to the same factory, and the 70+ export markets it already ships to keep the customs paperwork routine rather than experimental.
- Certificates in the manufacturing entity's name — no broker in the middle of your compliance chain
- Per-batch English reports travel with the shipment — customs reads the batch, not a brochure
Frequently Asked Questions
Can you support our product registration in our market?
Yes. ASL assembles the registration support pack — certificates in the manufacturing entity's name (FDA registration nos. 3016457665 and 3039282838, EU CE (MDR) to 2029-08-05, ISO 13485, the Class I filing, FSC), product test documentation and the English specification — so your local registration agent works from factory-held documents rather than broker-assembled ones.
Are the certificates in the factory's name or a trading company's?
In the manufacturing entity's name. This matters at customs and in tenders: a certificate held by a related sales company does not transfer to a product made in a factory that holds none. The registration numbers are printed on the certificates themselves and can be verified independently.
What documents does each shipment include?
The standard shipment pack covers the commercial invoice, packing list, customs declaration and clearance documents, and per-batch English test documentation; certificate copies and the specification sheet are provided with the order. Marine insurance can be arranged for the transit leg.
Do the test reports match the actual shipped batch?
Yes. ISO 10993-5 / -10 / -23 biocompatibility documentation is maintained per product family, and per-batch inspection records under ISO 13485 connect the shipped batch codes to the released specification — the reports reference the batch your warehouse receives, not a generic sample.
Which certifications does the factory hold overall?
ISO 13485 (2023-10-07 to 2026-10-06), ISO 9001 and ISO 14001 certified, ISO 45001 (2025-06-11 to 2028-06-10), FSC certified, EU CE (MDR) 2024-08-06 to 2029-08-05, FDA registrations in both China and Malaysia, and the China Class I medical device filing no. 20190011 with a medical device production licence.
How fast can a fully documented order ship?
Standard lead time depends on specification and volume; document preparation runs in parallel with production. For time-critical restock orders, the group completes expedited production and shipment in approximately 45 days via shared scheduling across its China and Malaysia bases, with the document pack prepared for the booking.
Start With Your Market's Document List
Send your destination market and product family. ASL returns the applicable certificate set, a sample per-batch report and the export document list for your shipment — so your compliance chain starts at the factory, not at a broker's desk.
More FAQs
Contact Aishule Hygiene Products
- Address (China HQ): Northwest Corner, Qiyang Road and Industrial 3 road intersection, High-tech Zone, Linyi, Shandong, CHINA
- Address (Malaysia Office): Advanced Safety Lifecare Sdn. Bhd.
LOT 7962, BATU 22, JALAN JOHOR BAHRU-AIR HITAM, 81000 KULAI, JOHOR, MALAYSIA
- Tel: +86-539-8488855 / +86-539-8488865
- Email: info@jingxincare.com
- Business hours: Mon - Fri 9:00 - 21:00
- Send an inquiry