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Albumin - BCG
EUDAMEDClass IVD General (EU MDR)
Ref D-601 001Ref D-601 003Ref D-601 002
Identity
- Trade Name
- Albumin - BCG EUDAMED
- Device Name
- Albumin - BCG EUDAMED
- Model / Reference
- D-601 001 EUDAMEDD-601 003 EUDAMEDD-601 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182700720 EUDAMED62230182700898 EUDAMED62230182700966 EUDAMED
- Basic UDI-DI
- B-62230182700720 EUDAMEDB-62230182700898 EUDAMEDB-62230182700966 EUDAMED
- EMDN Code
- W01010201 ALBUMIN (CC) 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
Albumin - BCG by Kalians 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-62230182700720 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kalians Corporation
- EUDAMED SRN
- EG-MF-000050142
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED b314920e-e23f-442c-bf61-e206b9559072 61 fields · synced Aug 3, 2026
- EUDAMED 57adf37a-274a-49c9-989e-e0c1dfc9ffca 61 fields · synced May 16, 2026
- EUDAMED 3a99e448-db10-41ff-8f71-5a7480853b71 61 fields · synced May 17, 2026