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Ferritin Rapid test cassette
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref OFE-402HRef OFE-NR402QJ-25R1Ref OFE-NR402Q-25R1Ref OFE-NR402Q-25R3Ref OFE-NR402QJ-10R3Ref OFE-NR402QB-10R1Ref OFE-NR402QB-10R3Ref OFE-NR402QB-25R1Ref OFE-NR402Q-10R1
Identity
- Trade Name
- Ferritin Rapid test cassette EUDAMEDFerritin Rapid Test EUDAMED
- Device Name
- Ferritin Rapid test cassette EUDAMEDFerritin Rapid Test EUDAMED
- Model / Reference
- OFE-402H EUDAMEDOFE-NR402QJ-25R1 EUDAMEDOFE-NR402Q-25R1 EUDAMEDOFE-NR402Q-25R3 EUDAMEDOFE-NR402QJ-10R3 EUDAMEDOFE-NR402QB-10R1 EUDAMEDOFE-NR402QB-10R3 EUDAMEDOFE-NR402QB-25R1 EUDAMEDOFE-NR402Q-10R1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983100120 EUDAMED06936983116213 EUDAMED06936983116251 EUDAMED06936983126533 EUDAMED06936983126564 EUDAMED06936983115834 EUDAMED06936983126540 EUDAMED06936983115841 EUDAMED06936983101141 EUDAMED06936983116244 EUDAMED07350123504484 EUDAMED
- Basic UDI-DI
- B-06936983100120 EUDAMED6970277510005PYQ EUDAMEDB-06936983101141 EUDAMEDB-07350123504484 EUDAMED
- EMDN Code
- W0102070102 FERRITIN EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass B EUDAMED
- Market of Registration
- Germany EUDAMEDIreland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Ferritin Rapid test cassette by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD devices for self-testing — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06936983100120 | Class IVD devices for self-testing | Active |
| EUDAMED | European Union | CE/IVDD | B-06936983100120 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (11)
- EUDAMED 4e56fd9f-8358-4cff-8230-c83c5dfac097 61 fields · synced Oct 6, 2026
- EUDAMED 0370f9fd-ed3a-481e-8ff0-b507287f7ddf 61 fields · synced May 17, 2026
- EUDAMED aef66223-5cea-4722-aef3-4d9410528f11 61 fields · synced May 18, 2026
- EUDAMED 370dacc0-e5c6-4b3b-804d-b82a441ee956 61 fields · synced May 18, 2026
- EUDAMED e3733a55-dbd2-4d1e-bb49-7bdb90b3e190 61 fields · synced May 18, 2026
- EUDAMED 92d35697-9934-464e-9deb-3b543709e2e7 61 fields · synced May 18, 2026
- EUDAMED 5e350a7d-b249-4822-9b36-8064f12c7b96 61 fields · synced May 18, 2026
- EUDAMED b634a45d-a398-446e-929f-42e411795c72 61 fields · synced May 19, 2026
- EUDAMED f7d3bb8e-ff17-4771-94bb-f768b3986221 61 fields · synced May 19, 2026
- EUDAMED 67dd91a3-e234-47da-a05e-4d21b0b46bb1 61 fields · synced May 19, 2026
- EUDAMED 6368ea17-fca5-4567-89e7-3541d81af878 61 fields · synced Jul 22, 2026