Identity
- Device Name
- Pean Hemostatic Fcps Delicate cvd 16cm EUDAMED
- Model / Reference
- 07023116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003617585 EUDAMED
- Basic UDI-DI
- 8964003617896400361758588 EUDAMED
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE 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
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Acetabular orthopaedic reamer
Pean Hemostatic Fcps Delicate cvd 16cm by Crimson International — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8964003617896400361758588 | Class I | Active |
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Manufacturer
- Manufacturer
- Crimson International
- EUDAMED SRN
- PK-MF-000035275
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 264bdcae-bc87-414e-bb94-115444ad6805 61 fields · synced Jul 11, 2026