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Carevance D15
EUDAMEDClass IIb (EU MDR)
Ref 8180000-002Model Carevance D12 Carevance D15 Carevance D19
Identity
- Trade Name
- Carevance D15 EUDAMED
- Device Name
- Carevance D12 Carevance D15 Carevance D19 EUDAMED
- Model / Reference
- Carevance D12 Carevance D15 Carevance D19 EUDAMED8180000-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195278878687 EUDAMED
- Basic UDI-DI
- 08406821BUG005857T EUDAMED
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Carevance D15 by GE Medical Systems CO. Ltd — Class IIb — 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 | 08406821BUG005857T | Class IIb | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems CO. Ltd
- EUDAMED SRN
- CN-MF-000001856
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED 6fd53094-e762-4a14-ac91-6ebeb82015e3 61 fields · synced Oct 6, 2026