Regulatory position
Stated precisely, because a regulatory claim that cannot be checked is worse than none.
United States — establishment registration
Both of the group’s plants are registered establishments with the U.S. Food and Drug Administration, and both registrations are current for FY 2026. The numbers are public and can be looked up.
| Fujian Dashan Paper Co., Ltd — Quanzhou, China | 3013123550 |
|---|---|
| USA Big Mountain Paper Inc. — Jacksonville, Florida | 3024988170 |
Product codes listed for Quanzhou
All are Class I devices and exempt from 510(k).
What registration is not
Registering an establishment is not an approval. Under 21 CFR 807.39, representing it as one is misbranding. So we write FDA-registered establishment, we give the number so you can verify it, and we never write “FDA approved”, never write “FDA certified”, and never show the agency’s logo.
European Union — CE marking under the MDR
We hold declarations of conformity under Regulation (EU) 2017/745 for three families, each with its Annex I documentation:
- Adult diapers
- Underpads
- Insert pads
Three families, and we list them rather than writing “our products are CE marked”. Absorbent underwear, wipes, baby and feminine hygiene are not covered by these declarations.
United Kingdom — UKCA
We hold a declaration of conformity under the UK Medical Devices Regulations 2002 for adult diapers: brief styles XS to 2XL and pant styles XS to 3XL. Class I, Rule 1 of Annex IX, assessed under Part II of the UK MDR 2002, against BS EN ISO 20417, 14971 and 15223-1 and the ISO 10993 series. Technical file UKCA-TCF-002, signed 11 July 2024. Our UK Responsible Person is SUNGO Certification Company Limited, 70 Gracechurch Street, London EC3V 0HR.
Read it for what it is. It covers adult diapers, briefs and pants — our underpads and insert pads are covered by the EU declarations above, not by this one. And like any Class I declaration it is the manufacturer’s own: no approved body is involved, and we will not dress it up as one.
UDI
UDI-DI identifiers are assigned for the devices concerned and held with the technical documentation.
Forest sourcing — PEFC chain of custody
The plant holds a chain-of-custody certificate issued by SGS under the Chinese CFCC scheme (GB/T 28952-2024, endorsed by PEFC ST 2002:2020). It can be checked on the CNCA register.
| Certificate | SGSCN-CFCC-COC-001208 |
|---|---|
| Valid | 1 Dec 2024 — 30 Nov 2029 |
| Method | Physical separation, 100 % certified |
Scope: buying PEFC/CFCC-certified pulp, tissue and nonwoven, and making and selling certified adult diapers, underpads and ordinary wet wipes. It covers the fibre we buy and the chain it travels, not the performance of the product.
Shelf life — five years, tested
Adult diapers were held 58 days under ASTM F1980-21, the accelerated ageing that models five years on a shelf, and the packaging was inspected to ASTM F1886/F1886M before and after. Both inspections met the standard. The work was done by a CNAS-accredited laboratory (L10066), report SSMT-R-2025-13611-01B, 28 July 2025. It substantiates the shelf life of the pack — it is not a claim about how much the product absorbs after five years.
ISO, and what we will not claim
The plant holds ISO 9001:2015 and ISO 13485:2016 certificates issued by ICAS under the Chinese accreditation scheme (CNCA-R-2003-117), covering the production and export of diapers, wet wipes and sanitary pads. We do not print a validity date on a web page: ask us and we will send the certificate itself, with its dates, so you can check it on the CNCA register. We hold no BRC certification, and we will not imply otherwise. If a certificate is a condition of your programme, say so early — it is a decision about the plant, not a line in a tender.