Produced under a Class I medical device manufacturing filing in a Class 100,000 cleanroom for hospitals, check-up centres and care institutions.
A medical underpad differs from a standard care pad not in appearance but in the production system and the channel it may enter. To supply hospitals and medical check-up centres legally, it must be manufactured under a Class I medical device manufacturing filing in a cleanroom. Our site combines the filing with a Class 100,000 cleanroom and a Class 10,000 laboratory.
The common specification is 60x90 cm, with institutional bulk sizes available on request. Sterilisation options (UV, ozone, EO and irradiation) are matched to the product category rather than applied uniformly. Every shipment can be accompanied by the filing documentation, a third-party batch test report and the required invoicing.
Structures listed below are common customisation directions. Final dimensions, grammage and material ratios are fixed at sample sign-off.
| Parameter | Common options (confirmed at sample sign-off) |
|---|---|
| Product class | Cleaning care pad type, managed as a Class I medical device |
| Common size | 60x90 cm; institutional bulk sizes customisable |
| Production environment | Class 100,000 cleanroom plus Class 10,000 laboratory |
| Documents per shipment | Class I medical device manufacturing filing, batch third-party test report, invoicing |
| Supply model | Hospital tender orders and institutional annual frame contracts, with reserved capacity |
Real product and packaging photographs. Own-brand packs shown here can be replaced with your artwork for private-label orders.
Filing plus cleanroom production is what opens hospital and institutional channels.
15 lines flex to reserve capacity for tender and annual contracts.
Filing, licence documents and batch reports can be supplied for institutional onboarding review.
Yes. The Class I medical device manufacturing filing, business licence, production licence documents and batch test reports can be provided for hospital and health-authority review.
Yes. Capacity is reserved in advance for tender and annual frame orders across the 15-line system.
Yes, within the compliant system. We support packaging copy compliance and the filing documentation package.
A third-party test report accompanies every batch. The certification register lists ISO9001 and ISO14001 with their real certificate numbers and marks all other qualifications as documentation to be confirmed rather than claiming them as certified. Sample batch reports can be supplied on request.
Send the size, grammage, estimated quantity and target market. Phone / WhatsApp: +86 13869876727 · Reply within 24 hours on working days.