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MINDRAY PM-9000/PM-8000/PM-7000/VS-800, MEC-1200 VET/BeneView T5/T8/BeneHeart D6
EUDAMEDClass I (EU MDR)
Ref ACC-5020/16R3Model Accu-PlusRef ACC-5020/16R4
Identity
- Trade Name
- MINDRAY PM-9000/PM-8000/PM-7000/VS-800, MEC-1200 VET/BeneView T5/T8/BeneHeart D6 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-5020/16R3 EUDAMEDACC-5020/16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814733 EUDAMED09551019814740 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551019814733 EUDAMED09551019814740 EUDAMED
- EMDN Code
- Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MINDRAY PM-9000/PM-8000/PM-7000/VS-800, MEC-1200 VET/BeneView T5/T8/BeneHeart D6 by Isd Meditech Sdn. Bhd. — Class I — MDR — listed in EUDAMED
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 | 955101981MCRP-APNG | Class I | Active |
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Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 041411a9-6f8b-4b52-91a2-f3dda23529cb 61 fields · synced Oct 6, 2026
- EUDAMED 8e6fff88-c692-44e1-b88d-1dadac87bd45 61 fields · synced May 19, 2026