Identity
- Trade Name
- NEGATOSKOP(DOUBLE) EUDAMED
- Device Name
- NEGATOSCOPE EUDAMED
- Model / Reference
- TM-F 6004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698943381137 EUDAMED
- Basic UDI-DI
- 869894338NGTSZU EUDAMED
- Direct Marketing DI
- 08698943381137 EUDAMED
- EMDN Code
- Z11069005 DIAGNOSTIC IMAGING WORKSTATIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tissue specimen x-ray system IVD
Negatoskop(double) by Tur-Med Hastane Malz. San. Tic. Ltd. Şti. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 869894338NGTSZU | Class I | Active |
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Manufacturer
- Manufacturer
- Tur-Med Hastane Malz. San. Tic. Ltd. Şti.
- EUDAMED SRN
- TR-MF-000018608
Sources (1)
- EUDAMED 48fc697e-4f32-4d84-983f-7211601b0210 61 fields · synced Jun 18, 2026