Identity
- Trade Name
- Beaule Cup Impactor Head 56mm EUDAMED
- Device Name
- Impactor EUDAMED
- Model / Reference
- 4576-02-56 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840277133403 EUDAMED
- Basic UDI-DI
- 8402771INNOIMPACT01T2 EUDAMED
- Direct Marketing DI
- 00840277133403 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Beaule Cup Impactor Head 56mm by Innomed, Inc. — 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 | 8402771INNOIMPACT01T2 | Class I | Active |
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Manufacturer
- Manufacturer
- Innomed, Inc.
- EUDAMED SRN
- US-MF-000014761
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED 2290860b-751b-4bd9-a583-235be871bfd2 61 fields · synced Jun 19, 2026