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Imipenem
EUDAMEDClass B (EU MDR)
Ref 0078B10Ref E110913 (W) Ref 0078B05Ref E110913 (K)
Identity
- Trade Name
- IMIPENEM EUDAMED
- Device Name
- MIC test IMIPENEM EUDAMEDIMIPENEM 10 (B) E110913 EUDAMED
- Model / Reference
- 0078B10 EUDAMEDE110913 (W) EUDAMED0078B05 EUDAMEDE110913 (K) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643973282 EUDAMED05902643981706 EUDAMED05902643970786 EUDAMED05902643978706 EUDAMED
- Basic UDI-DI
- 59026439BBMIMPJW EUDAMED59026439BASTIPMRT EUDAMED
- EMDN Code
- W0104080501 MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST) EUDAMEDW0104080502 IMPREGNATED DISKS, MULTI-DISKS & TABLETS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Poland 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
New Device
No
EUDAMED
Category: Antibacterial minimum inhibitory concentration (MIC) IVD
Imipenem by BioMaxima Spółka Akcyjna — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 59026439BBMIMPJW | Class B | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (4)
- EUDAMED 2fba9fea-a179-45da-ac69-13da40148d38 61 fields · synced Jul 24, 2026
- EUDAMED 881eeebc-3324-4ff1-8f95-b0f7369cee8c 61 fields · synced May 16, 2026
- EUDAMED f9ebd917-37e7-4625-8364-ced5ee2f1d0a 61 fields · synced May 17, 2026
- EUDAMED b81458b3-b131-44f0-a504-3e1ab05dc9ff 61 fields · synced May 18, 2026