Identity
- Trade Name
- DECG Legplate Adapter Cables EUDAMED
- Device Name
- DECG Legplate Adapter Cables EUDAMED
- Model / Reference
- FDELA-SL01-SPE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941691981107 EUDAMED
- Basic UDI-DI
- 69416919ORANTECH02QR EUDAMED
- EMDN Code
- Z12080185 PRENATAL DIAGNOSTIC INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
DECG Legplate Adapter Cables by Orantech Inc. — 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 | 69416919ORANTECH02QR | Class I | Active |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (1)
- EUDAMED 8d5905a6-276b-4191-b361-7ef908dc7191 61 fields · synced Jun 19, 2026