Identity
- Trade Name
- Central Monitoring System EUDAMED
- Device Name
- Central Monitoring System EUDAMED
- Model / Reference
- PM-2000 EUDAMED90720101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937683428163 EUDAMED
- Basic UDI-DI
- B-06937683428163 EUDAMED
- EMDN Code
- Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Central Monitoring System by Shenzhen Biocare Bio-Medical Equipment Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06937683428163 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000005653
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9c0b3ed1-8d77-4339-bf06-131c3665eea8 61 fields · synced Jun 18, 2026