Identity
- Device Name
- Paraffin gauze EUDAMED
- Model / Reference
- PFG1010-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 13615370004233 EUDAMED03615370004236 EUDAMED
- Basic UDI-DI
- B-13615370004233 EUDAMEDB-03615370004236 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Paraffin gauze by Zhende Medical Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-13615370004233 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhende Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009961
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED c76fd49e-5a3a-4317-9854-19ae2182e608 61 fields · synced Jul 25, 2026
- EUDAMED 74dffc58-d024-41b5-adbf-df802bbdc9f3 61 fields · synced May 18, 2026