Identity
- Device Name
- AZT EUDAMED
- Model / Reference
- 8004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588007926438 EUDAMED
- Basic UDI-DI
- B-08588007926438 EUDAMED
- EMDN Code
- W0104080501 MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Slovakia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
No
EUDAMED
Category: Antibacterial minimum inhibitory concentration (MIC) IVD
Azt by Diagnostics s.r.o. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Antibacterial minimum inhibitory concentration (MIC) IVD.
- MOXIFLOXACIN — BioMaxima Spółka Akcyjna · Class B
- ETEST® Benzylpenicillin (PG) — BIOMERIEUX , INC. · Class II
- AMPHOTERICIN B — BioMaxima Spółka Akcyjna · Class B
- ETEST® Minocycline (MC) — BIOMERIEUX , INC. · Class II
- CEFTOLOZANE-TAZOBACTAM — BioMaxima Spółka Akcyjna · Class B
- Etest® TIGECYCLINE — BIOMERIEUX , INC. · Class II
- VANCOMYCIN — BioMaxima Spółka Akcyjna · Class B
- ETEST® Ertapenem (ETP) — BIOMERIEUX , INC. · Class II
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-08588007926438 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostics s.r.o.
- EUDAMED SRN
- SK-MF-000038255
Sources (1)
- EUDAMED 7d9146bd-de46-4165-8a40-cce0bfac8374 61 fields · synced Jul 11, 2026