Identity
- Trade Name
- Harn1 EUDAMED
- Device Name
- Harnais EUDAMED
- Model / Reference
- Harn1 harnais EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770021816016 EUDAMED
- Basic UDI-DI
- 3770021816HARNAISB2 EUDAMED
- EMDN Code
- Z12040280 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Harn1 by Mdb Texinov — 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 | 3770021816HARNAISB2 | Class I | Active |
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Manufacturer
- Manufacturer
- Mdb Texinov
- EUDAMED SRN
- FR-MF-000001728
Sources (1)
- EUDAMED 7c4a7bcd-9ae1-42bd-aa66-e3991d344666 61 fields · synced Jul 14, 2026