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Tigecycline
EUDAMEDClass B (EU MDR)
Ref 0150B30Ref E112056 (B)Ref E112056 (W)Ref 0150B10Ref E112056 (K)
Identity
- Trade Name
- TIGECYCLINE EUDAMED
- Device Name
- MIC test TIGECYCLINE EUDAMEDTIGECYCLINE 15 (B) E112056 EUDAMED
- Model / Reference
- 0150B30 EUDAMEDE112056 (B) EUDAMEDE112056 (W) EUDAMED0150B10 EUDAMEDE112056 (K) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643976504 EUDAMED05902643901216 EUDAMED05902643982215 EUDAMED05902643974005 EUDAMED05902643979215 EUDAMED
- Basic UDI-DI
- 59026439BBMTGCK9 EUDAMED59026439BASTTGCS3 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
Tigecycline by BioMaxima Spółka Akcyjna — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Antibacterial minimum inhibitory concentration (MIC) IVD.
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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 | 59026439BBMTGCK9 | Class B | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (5)
- EUDAMED 39f512c2-8daf-4e35-8398-06530fc533d0 61 fields · synced Aug 1, 2026
- EUDAMED b58800e9-864c-451d-96ff-43b3a98ce242 61 fields · synced May 18, 2026
- EUDAMED 3e868ccc-e41a-4f75-a20b-8dca34f1585b 61 fields · synced May 18, 2026
- EUDAMED 49bedc12-7407-4bc2-88c6-278f0177b523 61 fields · synced May 18, 2026
- EUDAMED 5cd44614-b84e-4681-9580-d5ffe39fdfec 61 fields · synced May 18, 2026