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LDL-D R1:2x15 R2:1x10ml (BS-200)
EUDAMEDClass IVD General (EU MDR)
Ref 001635Ref 001363
Identity
- Trade Name
- LDL-D R1:2x15 R2:1x10ml (BS-200) EUDAMEDLDL-D R1:2x15 R2:1x10ml EUDAMED
- Device Name
- LDL-D R1:2x15 R2:1x10ml (BS-200) EUDAMEDLDL-D R1:2x15 R2:1x10ml EUDAMED
- Model / Reference
- 001635 EUDAMED001363 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05213003192138 EUDAMED05213003191049 EUDAMED
- Basic UDI-DI
- B-05213003192138 EUDAMEDB-05213003191049 EUDAMED
- EMDN Code
- W01010221 LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
LDL-D R1:2x15 R2:1x10ml (BS-200) by Biotechnological Applications Ltd — Class IVD General — 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-05213003192138 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biotechnological Applications Ltd
- EUDAMED SRN
- GR-MF-000033000
Sources (2)
- EUDAMED 2cd1ad58-3e43-429a-9186-2baf73741b3f 61 fields · synced Jul 14, 2026
- EUDAMED 2de46bea-94c4-4a09-8f3f-fe70976d687d 61 fields · synced May 18, 2026