Identity
- Trade Name
- NM/CT 860 EUDAMED
- Device Name
- NM/CT 860 EUDAMED
- Model / Reference
- NM/CT 860 EUDAMED5804395 PCM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682142137 EUDAMED
- Basic UDI-DI
- B-00840682142137 EUDAMED
- EMDN Code
- Z11020201 CT/GAMMA CAMERA SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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 860 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-00840682142137 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
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 28d0c7b4-9e11-4146-bc65-e1381b0cee66 61 fields · synced Jun 18, 2026