Identity
- Trade Name
- ASTar Instrument EUDAMEDFDA UDI
- Generic Name
- Antimicrobial susceptibility analyser IVD FDA UDI
- Device Name
- ASTar Instrument EUDAMEDAntimicrobial Susceptibility Testing FDA UDI
- Model / Reference
- 50003135 EUDAMEDFDA UDI
- Description
- Antimicrobial Susceptibility Testing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350136800047 EUDAMEDFDA UDI
- Basic UDI-DI
- 735013680500031354U EUDAMED
- 510(k) Number
- K221688 FDA UDI
- FDA Product Code
- SAN FDA UDILON FDA UDI
- EMDN Code
- W0203010180 ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Antimicrobial susceptibility analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.1650 FDA UDI866.1645 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
EUDAMED
New Device
Yes
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ASTar Instrument by Q-Linea AB — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 735013680500031354U | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Q-linea AB
- EUDAMED SRN
- SE-MF-000013026
Sources (2)
- EUDAMED ea6c8afd-2cc4-45df-9713-9d6394b560b9 61 fields · synced Jun 8, 2026
- FDA UDI 558cd492-6a24-45ce-a805-f70122ce51c5 36 fields · synced May 29, 2026