Identity
- Trade Name
- Apifex BASIC EUDAMED
- Device Name
- Wound Dressing EUDAMED
- Model / Reference
- 51002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953395558318 EUDAMED
- Basic UDI-DI
- 69533955WD0010001RH EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Apifex BASIC by Jinhua Jingdi Medical Supplies Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69533955WD0010001RH | Class I | Active |
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Manufacturer
- Manufacturer
- Jinhua Jingdi Medical Supplies Co., Ltd.
- EUDAMED SRN
- CN-MF-000009653
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 3ff71f1d-db42-4a13-8e3c-7df1203fd217 61 fields · synced Jun 20, 2026