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omegapack Ortopédiai műtéti szett 389
EUDAMEDClass IIa (EU MDR)
Ref OP-ORT-01389
by ZARYS International Spółka z ograniczoną odpowiedzialnością
Identity
- Trade Name
- omegapack Ortopédiai műtéti szett 389 EUDAMED
- Device Name
- omegapack Ortopédiai műtéti szett 389 EUDAMED
- Model / Reference
- OP-ORT-01389 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904109612575 EUDAMED
- Basic UDI-DI
- B-05904109612575 EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
omegapack Ortopédiai műtéti szett 389 by ZARYS International Spółka z ograniczoną odpowiedzialnością — Class IIa — MDD — listed in EUDAMED
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Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05904109612575 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000000410
Sources (1)
- EUDAMED 6cdcac24-9d58-496f-900d-6f20ec418770 61 fields · synced Oct 9, 2026