Identity
- Trade Name
- ApifexFIXFOAM EUDAMED
- Device Name
- Foam dressing EUDAMED
- Model / Reference
- G3101 EUDAMED51044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926365598140 EUDAMED
- Basic UDI-DI
- 69263655200037U EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb 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
ApifexFIXFOAM by Zhejiang Longterm Medical Technology Co., Ltd. — Class IIb — 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 | 69263655200037U | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhejiang Longterm Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000001161
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 51bdbfae-de0b-4185-b34d-a6063fd2c901 61 fields · synced Oct 6, 2026