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Unity 9000 Digital Video Processor
EUDAMEDClass I (EU MDR)
Ref 07-9000Model UNITY-9000
Identity
- Trade Name
- Unity 9000 Digital Video Processor EUDAMED
- Device Name
- UNITY-9000 Digital Video Processor EUDAMED
- Model / Reference
- UNITY-9000 EUDAMED07-9000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00874485003494 EUDAMED
- Basic UDI-DI
- 087448500UNITYKG EUDAMED
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Unity 9000 Digital Video Processor by Cogentix Medical, 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 | 087448500UNITYKG | Class I | Active |
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Manufacturer
- Manufacturer
- Cogentix Medical, Inc.
- EUDAMED SRN
- US-MF-000041661
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (1)
- EUDAMED aa3a064d-3ead-442d-87f0-03ff3eef24dd 61 fields · synced Jun 18, 2026