← Back to catalogue
Penumbra Smart Coil Wave Extra Soft, 1 mm x 1 cm
EUDAMEDFDA UDIClass III (EU MDR)
Ref 400SMTHXSFT0101Model Wave Extra Soft
Identity
- Trade Name
- Penumbra Smart Coil Wave Extra Soft, 1 mm x 1 cm EUDAMEDSmart Coil FDA UDI
- Generic Name
- Embolization implant kit FDA UDI
- Device Name
- Penumbra Smart Coil EUDAMEDSmtCoil-HelXSft, 1x1 FDA UDI
- Model / Reference
- Wave Extra Soft EUDAMED400SMTHXSFT0101 EUDAMEDFDA UDI
- Description
- SmtCoil-HelXSft, 1x1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D-SmartCoilVR EUDAMED00814548015590 FDA UDI
- Basic UDI-DI
- B-SmartCoilVR EUDAMED
- 510(k) Number
- K143218 FDA UDI
- FDA Product Code
- HCG FDA UDI
- EMDN Code
- C010402020301 EMBOLISATION COILS EUDAMED
- GMDN Term
- Embolization implant kit FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5950 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Penumbra Smart Coil Wave Extra Soft, 1 mm x 1 cm by Penumbra, Inc. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-SmartCoilVR | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Penumbra, Inc.
- EUDAMED SRN
- US-MF-000008514
- Authorised Representative
- Penumbra Europe GmbH DE-AR-000004997
Sources (2)
- EUDAMED b8dbf11e-6e96-49e1-aaec-f3f846c88da6 61 fields · synced Jul 20, 2026
- FDA UDI 0142f3e0-0418-4a02-9ff8-7f941390d73b 34 fields · synced May 30, 2026