Identity
- Device Name
- Monofilament EUDAMED
- Model / Reference
- 10013.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04745010564130 EUDAMED
- Basic UDI-DI
- 474501056410013B9 EUDAMED
- EMDN Code
- V030207 SENSITIVITY MEASUREMENTS DEVICES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Estonia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
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
Monofilament by 1m4 Oü — 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 | 474501056410013B9 | Class I | Active |
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Manufacturer
- Manufacturer
- 1m4 Oü
- EUDAMED SRN
- EE-MF-000040367
Sources (1)
- EUDAMED ba3a7ce1-149d-45cf-882b-14ef029a2577 61 fields · synced Jul 20, 2026