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Blood Lipid Test Strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref /Model PFS 30
Identity
- Device Name
- Blood Lipid Test Strip EUDAMED
- Model / Reference
- PFS 30 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-4-46P EUDAMED
- Basic UDI-DI
- B-4-46P EUDAMED
- EMDN Code
- W0101060109 MULTIPLE PARAMETER BLOOD TEST EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Blood Lipid Test Strip by URIT Medical Electronic Co., Ltd. — Class IVD devices for self-testing — 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-4-46P | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f7334ea9-ef0d-489c-98a0-889999c205d9 61 fields · synced Aug 1, 2026