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Transferrin and Fecal Occult Blood and Haptoglobinhemoglobin Combo Test Device
EUDAMEDClass IVD General (EU MDR)
Ref MT-F43M002
Identity
- Trade Name
- Transferrin and Fecal Occult Blood and Haptoglobinhemoglobin Combo Test Device EUDAMED
- Device Name
- Transferrin and Fecal Occult Blood and Haptoglobinhemoglobin Combo Test Device EUDAMED
- Model / Reference
- MT-F43M002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804817459 EUDAMED
- Basic UDI-DI
- B-06952804817459 EUDAMED
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
Transferrin and Fecal Occult Blood and Haptoglobinhemoglobin Combo Test Device by Assure Tech. (hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in…
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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-06952804817459 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 5a93f4b1-3818-4d64-9056-df0f0b552bac 61 fields · synced Oct 6, 2026