Identity
- Trade Name
- Handset EUDAMED
- Device Name
- Handset EUDAMED
- Model / Reference
- 1050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700002169716 EUDAMED
- Basic UDI-DI
- 57000021697SeromaSetFX EUDAMED
- EMDN Code
- A06010199 VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
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
Handset by Innoventa Medica ApS — 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 | 57000021697SeromaSetFX | Class I | Active |
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Manufacturer
- Manufacturer
- Innoventa Medica ApS
- EUDAMED SRN
- DK-MF-000013980
Sources (1)
- EUDAMED 57cc1ade-e5d6-45d8-80b0-3f488c148d5b 61 fields · synced Jul 10, 2026