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Automatic Chromosome Micrograph Scanning System
EUDAMEDClass IVD General (EU MDR)
Ref /Model RT-i1000, RT-i1100, RT-i1200, RT-i1300
Identity
- Device Name
- Automatic Chromosome Micrograph Scanning System EUDAMED
- Model / Reference
- RT-i1000, RT-i1100, RT-i1200, RT-i1300 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-60801GS EUDAMED
- Basic UDI-DI
- B-60801GS EUDAMED
- EMDN Code
- W0202050303 OPTICAL LABORATORY MICROSCOPES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Automatic Chromosome Micrograph Scanning System by Shenzhen Reetoo Biotechnology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-60801GS | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Reetoo Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000011699
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 09730bcb-052d-48d9-b1d4-2620b5d8d332 61 fields · synced Jul 14, 2026