Identity
- Trade Name
- NM 830 EUDAMED
- Device Name
- NM 830 EUDAMED
- Model / Reference
- NM 830 EUDAMED5797112 PCM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682142113 EUDAMED
- Basic UDI-DI
- B-00840682142113 EUDAMED
- EMDN Code
- Z11020105 FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITH ‘TOTAL BODY’ ACQUISITION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Nm 830 by GE Hualun Medical Systems Co., Ltd — Class IIa — 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-00840682142113 | Class IIa | 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 3aa25e9b-8aac-40ca-9209-8b64a9af9b65 61 fields · synced Jul 19, 2026