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ß-Ketone Control Solution L2
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref TD-4915
Identity
- Trade Name
- ß-Ketone Control Solution L2 EUDAMED
- Device Name
- ß-Ketone control solution EUDAMED
- Model / Reference
- TD-4915 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04713106024431 EUDAMED
- Basic UDI-DI
- B-04713106024431 EUDAMED
- EMDN Code
- W0101050205 DIABETES CONTROLS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ß-Ketone Control Solution L2 by Taidoc Technology Corporation — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-04713106024431 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- TaiDoc Technology Corporation
- EUDAMED SRN
- TW-MF-000017956
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED a081af67-5091-4799-8be7-8e155f7c9757 61 fields · synced Jun 18, 2026