Identity
- Device Name
- Multitest Card EUDAMED
- Model / Reference
- M01001-01 EUDAMEDM01001-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974675460350 EUDAMED06974675460367 EUDAMED
- Basic UDI-DI
- 697467546F80101B6 EUDAMED
- EMDN Code
- W0503900201 MICROSCOPE SLIDES EUDAMED
Classification
- Device Class
- Class A 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
No
EUDAMED
New Device
No
EUDAMED
Category: General specimen microscopy slide IVD, single-use
Multitest Card by Shenzhen Reetoo Biotechnology Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697467546F80101B6 | Class A | 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 (2)
- EUDAMED e2c6eeb1-5997-4c46-9465-ff2b7f37eff7 61 fields · synced Oct 6, 2026
- EUDAMED c7b8fdab-021c-4429-8d50-9b3079a541a9 61 fields · synced May 17, 2026