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Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay)
EUDAMEDClass IVD General (EU MDR)
Ref GXM-01
Identity
- Trade Name
- Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay) EUDAMED
- Device Name
- Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay) EUDAMED
- Model / Reference
- GXM-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970514080536 EUDAMED
- Basic UDI-DI
- B-06970514080536 EUDAMED
- EMDN Code
- W0105060303 CRYPTOCOCCUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay) by Genobio Pharmaceutical Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06970514080536 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- EUDAMED SRN
- CN-MF-000027997
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED a641066b-b7dd-46e3-98a3-5da7929d2e6d 61 fields · synced Jul 24, 2026