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VER-FIX Dwuczęściowe okularki do fototerapii
EUDAMEDClass I (EU MDR)
Ref 07012Ref 07011
Identity
- Trade Name
- VER-FIX Dwuczęściowe okularki do fototerapii EUDAMED
- Device Name
- VER-FIX Okularki do fototerapii EUDAMED
- Model / Reference
- 07012 EUDAMED07011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 59037193063624 EUDAMED59037193063488 EUDAMED
- Basic UDI-DI
- 59037193100421001AG EUDAMED
- EMDN Code
- V0201 PHOTOTHERAPY MASKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Category: Phototherapy eye protector, reusable
VER-FIX Dwuczęściowe okularki do fototerapii by Sinmed Spółka Z Ograniczoną Odpowiedzialnością — Class I — MDR — listed in EUDAMED
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Also classified as Phototherapy eye protector, reusable.
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- NeoShades® with Headstrap Phototherapy Eye Shields - Small — Neotech Products LLC · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 59037193100421001AG | Class I | Active |
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Manufacturer
- Manufacturer
- Sinmed Spółka Z Ograniczoną Odpowiedzialnością
- EUDAMED SRN
- PL-MF-000002789
Sources (2)
- EUDAMED 1eeb55e7-f324-4507-83b9-8a036d5a9a2e 61 fields · synced Jul 27, 2026
- EUDAMED 6fad7c24-9eba-403b-bd42-262864aed95e 61 fields · synced May 18, 2026