Identity
- Trade Name
- LDL-D R1:2x30 R2:1x20ml EUDAMEDLDL-D R1:2x30 R2:1x20ml (BS-200) EUDAMED
- Device Name
- LDL-D R1:2x30 R2:1x20ml EUDAMEDLDL-D R1:2x30 R2:1x20ml (BS-200) EUDAMED
- Model / Reference
- 000889 EUDAMED001634 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05213003190547 EUDAMED05213003192121 EUDAMED
- Basic UDI-DI
- B-05213003190547 EUDAMEDB-05213003192121 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 R1:2x30 R2:1x20ml 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-05213003190547 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biotechnological Applications Ltd
- EUDAMED SRN
- GR-MF-000033000
Sources (2)
- EUDAMED 7adcf70f-c064-4df7-b9c9-eeee361ad666 61 fields · synced Jul 27, 2026
- EUDAMED 411efee6-dc53-4974-b83f-4d613d2331f0 61 fields · synced May 19, 2026