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AdvanSure™ AlloScreen Max108 Panel
EUDAMEDClass IVD General (EU MDR)
Ref MXB0060K00Model AdvanSure™ AlloScreen Max108 Panel
Identity
- Trade Name
- AdvanSure™ AlloScreen Max108 Panel EUDAMED
- Device Name
- AdvanSure™ AlloScreen Max108 Panel EUDAMED
- Model / Reference
- MXB0060K00 EUDAMEDAdvanSure™ AlloScreen Max108 Panel EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800050290459 EUDAMED08809975010050 EUDAMED
- Basic UDI-DI
- B-08800050290459 EUDAMEDB-08809975010050 EUDAMED
- EMDN Code
- W01020201,W01020204 EUDAMED
Classification
- Device Class
- Class IVD General 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
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
AdvanSure™ AlloScreen Max108 Panel by Invitros Co., 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-08800050290459 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Invitros Co., Ltd
- EUDAMED SRN
- KR-MF-000023980
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 05f553d4-60c4-4984-9181-88389acacc34 61 fields · synced Jul 27, 2026
- EUDAMED f61e61bf-ce81-42b6-bc6a-d977c6eed2f8 61 fields · synced Jul 27, 2026