← Back to catalogue
Impaction Plate for Versafit DM Cup Size 58
EUDAMEDClass I (EU MDR)
Ref 01.26.10.0458
Identity
- Trade Name
- Impaction Plate for Versafit DM Cup Size 58 EUDAMED
- Device Name
- Enztec Cup Impactors EUDAMED
- Model / Reference
- 01.26.10.0458 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421028114110 EUDAMED
- Basic UDI-DI
- 942102811GMN00092B EUDAMED
- Direct Marketing DI
- 09421028114110 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Impaction Plate for Versafit DM Cup Size 58 by Enztec Limited — 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 | 942102811GMN00092B | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED aac0233f-ec78-4f40-96c7-a7be0298b18b 61 fields · synced Jul 23, 2026