Identity
- Trade Name
- Fitting/Adapters EUDAMED
- Device Name
- Fitting/Adapters EUDAMED
- Model / Reference
- TNC-PH-ST001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941691980643 EUDAMED
- Basic UDI-DI
- 69416919ORANTECH20QT EUDAMED
- EMDN Code
- Z1203019085 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - 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
Fitting/Adapters 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 | 69416919ORANTECH20QT | 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 e480d3eb-bc98-46b7-9801-28208fe98bf4 61 fields · synced Jun 19, 2026