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Hydrozid PRECISE
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 201Model FORCE510(k) K221897
Identity
- Trade Name
- Hydrozid PRECISE EUDAMED
- Device Name
- Hydrozid FORCE EUDAMED
- Model / Reference
- FORCE EUDAMED201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05744002424024 EUDAMED
- Basic UDI-DI
- 574400242Hydrozid2013NE EUDAMED
- EMDN Code
- V9099,Z120102 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hydrozid PRECISE by BIBAWO Medical A/S — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221897 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 574400242Hydrozid2013NE | Class IIa | Active |
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Manufacturer
- Manufacturer
- BIBAWO Medical A/S
- EUDAMED SRN
- DK-MF-000024659
Sources (2)
- EUDAMED 6afb05b6-0f42-4216-8c0c-84209528202a 85 fields · synced Jun 18, 2026
- FDA 510(k) K221897 1 fields · synced May 18, 2026