Identity
- Trade Name
- NM/CT 850 EUDAMED
- Device Name
- NM/CT 850 EUDAMED
- Model / Reference
- NM/CT 850 EUDAMED5804394 PCM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682142144 EUDAMED
- Basic UDI-DI
- B-00840682142144 EUDAMED
- EMDN Code
- Z11020201 CT/GAMMA CAMERA SYSTEMS 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nm/Ct 850 by GE Hualun Medical Systems 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-00840682142144 | Class IIb | Active |
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Manufacturer
- Manufacturer
- GE HUALUN MEDICAL SYSTEMS CO. Ltd
- EUDAMED SRN
- CN-MF-000001189
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED bbf6abce-4549-4238-99b3-058b3d2f362d 61 fields · synced Oct 6, 2026