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Coil 400 Complex Standard, 7mm x 20 cm
EUDAMEDClass III (EU MDR)
Ref 4002C0720Model Complex Standard
Identity
- Trade Name
- Coil 400 Complex Standard, 7mm x 20 cm EUDAMED
- Device Name
- Penumbra Coil 400 EUDAMED
- Model / Reference
- Complex Standard EUDAMED4002C0720 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-PC400UM EUDAMED
- Basic UDI-DI
- B-PC400UM EUDAMED
- EMDN Code
- C010402020301 EMBOLISATION COILS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Coil 400 Complex Standard, 7mm x 20 cm by Penumbra, Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-PC400UM | Class III | 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 120daf6c-f0f2-48d3-8125-ffe7854549d6 61 fields · synced Jul 23, 2026