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Z1203020285
EUDAMEDClass I (EU MDR)
Ref EC-3053RS-ARef EC-5016RS-ARef EC-3045G-I
Identity
- Trade Name
- Z1203020285 EUDAMED
- Device Name
- ECG Leadwires EUDAMED
- Model / Reference
- EC-3053RS-A EUDAMEDEC-5016RS-A EUDAMEDEC-3045G-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941691930778 EUDAMED06941691932291 EUDAMED06941691930440 EUDAMED
- Basic UDI-DI
- 69416919ORANTECH01QP EUDAMED
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose multi-parameter bedside monitor
Z1203020285 by Orantech Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69416919ORANTECH01QP | 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 (3)
- EUDAMED ed896cd9-a746-4421-a549-e1d4df0dde73 61 fields · synced Jul 10, 2026
- EUDAMED 39a253b0-174e-40bf-b75d-e58461f6b060 61 fields · synced May 18, 2026
- EUDAMED eda96af0-2172-4251-b5a4-2b272210737b 61 fields · synced May 18, 2026