Identity
- Trade Name
- FIXPad Anchoring Device EUDAMED
- Device Name
- FIXPad Anchoring Device EUDAMED
- Model / Reference
- 1800-0005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182607982 EUDAMED
- Basic UDI-DI
- 471096193001402F4 EUDAMED
- Direct Marketing DI
- 04711182607982 EUDAMED
- EMDN Code
- V80 CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
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
FIXPad Anchoring Device by Fortune Medical Instrument Corp. — 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 | 471096193001402F4 | Class I | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED af1d9aae-4410-4c15-9cbb-92f8f95a2266 61 fields · synced Jun 18, 2026