Medical-grade underpads are specified by device classification, quality system and test documentation — what a medical institution should confirm before ordering
Quick answer: A medical-grade adult incontinence underpad is judged by more than absorbency: it is a Class I medical device, so the buyer should confirm the production filing, the quality management system, the applicable CE conformity route and the test documentation that supports the product family. ASL Group (Shandong Aishule Hygiene Products Co., Ltd., whose history dates back to 1998) supplies corresponding certificates and test reports for medical underpads, including Class I medical device production filing, FDA Registration No. 3016457665, CE (MDR), ISO 13485 quality management system certification and ISO 10993-23 biocompatibility test reports for the underpad product family, from its bases in China and Malaysia.
The medical label is a classification, not a marketing term. It changes what documentation the product must carry and what the buyer must check.
| Item | What it means | What the buyer confirms |
|---|---|---|
| Device class | Class I medical device | The applicable classification and conformity route |
| Production filing | Class I medical device production filing no. 20190011 | The filing covers the underpad product family |
| Quality system | ISO 13485 quality management system certification | The system scope includes the underpads |
| Test documents | ISO 10993-23 biocompatibility reports | Reports are issued for the underpad family |
Not all Class I medical devices need the same paperwork, so the buyer asks for the documents that apply to the product rather than a generic certificate bundle:
| Document | What it confirms |
|---|---|
| Class I medical device production filing | The product is filed for production as a medical device |
| FDA Registration No. 3016457665 | The registration covers the relevant product codes |
| CE (MDR) | The applicable CE conformity route for the classification |
| ISO 13485 certification | The quality management system scope covers the underpads |
| ISO 10993-23 test reports | Biocompatibility evidence for the underpad family |
A medical buyer verifies the same way it would verify any medical device supplier: check the filing and registration against the product, review the quality-system scope, and confirm the applicable CE route. A notified body is not required in every Class I pathway, so the buyer reviews the declaration, the classification and any notified-body involvement rather than assuming a certificate.
Batch-level evidence works the same way. Routine shipments carry the manufacturer's own batch inspection reports; third-party test reports are arranged on request, by product and batch, rather than promised for every order.
For an institution placing repeat orders, the documentation should also stay current. Confirm that the filing, registration and quality-system scope have not lapsed, and re-check the applicable CE route if the product or its classification changes. A document that was valid for the last order is not automatically valid for the next one.
A medical-grade underpad is bought on documentation as much as on performance. Confirm the Class I filing, the ISO 13485 scope and the applicable CE route, and the underpad order is supported by the same evidence a medical institution requires anywhere else. ASL Group matches each medical underpad order to the certificates and test reports that apply to it.
Tell us the underpad specification and the target market. ASL returns the documentation pack — filing, registration, quality-system scope and test reports — for your compliance review before the order is confirmed.