Identity
- Trade Name
- Immuno-T At Home Blood Collection Kit EUDAMED
- Device Name
- Immuno-T At Home Blood Collection Kit EUDAMED
- Model / Reference
- AHBCK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065019690005 EUDAMED
- Basic UDI-DI
- 5065019690AHBCKUS EUDAMED
- EMDN Code
- W0501010299 CAPILLARY BLOOD COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Immuno-T At Home Blood Collection Kit by ImmunoServ Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: At Home Blood Collection Kit
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 | 5065019690AHBCKUS | Class A | Active |
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Manufacturer
- Manufacturer
- ImmunoServ Ltd
- EUDAMED SRN
- UK-MF-000049445
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (1)
- EUDAMED 16ea2a6a-af30-4cbc-ba7a-205cb1eb1eec 61 fields · synced Jun 19, 2026