Identity
- Trade Name
- MED-Fibers, Inc. EUDAMED
- Device Name
- MF-400-HPCS-ES EUDAMED
- Model / Reference
- MF-400-HPCS-ES EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00855950006790 EUDAMED
- Basic UDI-DI
- B-00855950006790 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
Yes
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
MediFibers, Inc.'s MED-Fibers, Inc. is a Class IIb medical device that utilizes Total-Laser Solution GmbH's Total-Laser technology to treat various conditions, including respiratory issues. Developed with human product features, this FDA-cleared device provides an accurate and precise measurement of lung volume.
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-00855950006790 | 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 ddd92ed9-235a-47fe-90e8-bac7345e1a98 61 fields · synced Jul 27, 2026