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LBgard Blood Tubes
EUDAMEDClass IVD General (EU MDR)
Ref 100372Model version 1.2
Identity
- Trade Name
- LBgard Blood Tubes EUDAMED
- Device Name
- LBgard Blood Tubes EUDAMED
- Model / Reference
- version 1.2 EUDAMED100372 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-USMF000013637LBG001FY EUDAMED
- Basic UDI-DI
- B-USMF000013637LBG001FY EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
LBgard Blood Tubes by Exact Sciences Corporation — 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-USMF000013637LBG001FY | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Exact Sciences Corporation
- EUDAMED SRN
- US-MF-000013637
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 7aaa4fe1-f9c3-4177-a715-6c92a405cc31 61 fields · synced Jul 18, 2026