Identity
- Trade Name
- MED-Fibers, Inc. EUDAMED
- Device Name
- MF-400/440-CON EUDAMED
- Model / Reference
- MF-400/440-CON EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00855950006691 EUDAMED
- Basic UDI-DI
- B-00855950006691 EUDAMED
- EMDN Code
- Z12011003 HOLMIUM SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
MED-Fibers, Inc. by Med -fibers Inc. — Class IIb — 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-00855950006691 | Class IIb | Active |
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Manufacturer
- Manufacturer
- MED-Fibers, Inc.
- EUDAMED SRN
- US-MF-000039524
- Authorised Representative
- Total-Laser Solution GmbH AT-AR-000021498
Sources (1)
- EUDAMED 5096f1a5-8613-46ec-920a-aaa311983f48 61 fields · synced May 23, 2026