Identity
- Trade Name
- Starter EUDAMED
- Device Name
- PTFE Guidewires (Vascular) EUDAMED
- Model / Reference
- SCMBF-121V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816349012778 EUDAMED
- Basic UDI-DI
- 081634901PTFEVASN2 EUDAMED
- EMDN Code
- C04020102 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Netherlands 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
Starter by Lake Region Medical — Class III — 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 | 081634901PTFEVASN2 | Class III | Active |
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Manufacturer
- Manufacturer
- Lake Region Medical
- EUDAMED SRN
- US-MF-000033013
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED faf16d9d-c08a-4ef2-a849-6343f2e8ee80 61 fields · synced Oct 7, 2026