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Penumbra Swift Coil Detachment Handle
EUDAMEDClass I (EU MDR)
Ref SDH1Model Penumbra Swift Coil Detachment Handle
Identity
- Trade Name
- Penumbra Swift Coil Detachment Handle EUDAMED
- Device Name
- Detachment Handle EUDAMED
- Model / Reference
- Penumbra Swift Coil Detachment Handle EUDAMEDSDH1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810169721544 EUDAMED
- Basic UDI-DI
- 081454801SDH185 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 Swift 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 | 081454801SDH185 | 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 1251da8e-3e1f-43b2-bc5d-a1d9e042b83e 61 fields · synced Jun 19, 2026