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GE Healthcare
EUDAMEDClass I (EU MDR)
Ref 5818864
by Graphic Controls Acquisition Corp d.b.a Nissha Medical Technologies
Identity
- Trade Name
- GE Healthcare EUDAMED
- Device Name
- Thermal Recording Chart Paper with Measuring Function EUDAMED
- Model / Reference
- 5818864 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00009336009466 EUDAMED
- Basic UDI-DI
- 009336Measuring-ChartGKS EUDAMED
- EMDN Code
- Z1302 DIAGNOSTIC REGISTRATION PAPERS EUDAMED
Classification
- Device Class
- Class I 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
GE Healthcare by Graphic Controls Acquisition Corp d.b.a Nissha Medical Technologies — Class I — 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 | 009336Measuring-ChartGKS | Class I | Active |
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Manufacturer
- EUDAMED SRN
- US-MF-000012773
- Authorised Representative
- NISSHA MEDICAL TECHNOLOGIES SAS FR-AR-000009795
Sources (1)
- EUDAMED 5e8cbb0e-83c0-4011-a343-9f6ed355a2f4 61 fields · synced Aug 2, 2026