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Penumbra Coil Detachment Handle
EUDAMEDClass I (EU MDR)
Ref RH1Model Penumbra Coil Detachment Handle
Identity
- Trade Name
- Penumbra Coil Detachment Handle EUDAMED
- Device Name
- Detachment Handle EUDAMED
- Model / Reference
- Penumbra Coil Detachment Handle EUDAMEDRH1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810169721032 EUDAMED
- Basic UDI-DI
- 081454801RHRA EUDAMED
- EMDN Code
- C010402020301 EMBOLISATION COILS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Penumbra Coil Detachment Handle by Penumbra, 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 | 081454801RHRA | Class I | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
- EUDAMED SRN
- US-MF-000008514
- Authorised Representative
- Penumbra Europe GmbH DE-AR-000004997
Sources (1)
- EUDAMED 513e90ff-227b-48f0-8584-b8ca03467f72 61 fields · synced Jun 19, 2026