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Streptococcus AST
EUDAMEDClass C (EU MDR)
Ref MD0202Model Automated Microbiology System AnalyzersRef MD0203
Identity
- Trade Name
- Streptococcus AST EUDAMED
- Device Name
- Streptococcus AST EUDAMED
- Model / Reference
- Automated Microbiology System Analyzers EUDAMEDMD0202 EUDAMEDMD0203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975577172624 EUDAMED06975577172631 EUDAMED
- Basic UDI-DI
- 697015090000065HC EUDAMED
- EMDN Code
- W0104080108 GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
New Device
No
EUDAMED
Streptococcus AST by Autobio Diagnostics Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697015090000065HC | Class C | Active |
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Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 89451637-f0c6-483c-8827-22172647dcef 61 fields · synced Jul 26, 2026
- EUDAMED 6a0a297d-f69d-4edf-a7cf-4374a73c3f17 61 fields · synced May 19, 2026