← Back to catalogue
VER-FIX Jednoczęściowe okularki do fototerapii
EUDAMEDClass I (EU MDR)
Ref 07001
Identity
- Trade Name
- VER-FIX Jednoczęściowe okularki do fototerapii EUDAMED
- Device Name
- VER-FIX Okularki do fototerapii EUDAMED
- Model / Reference
- 07001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 59037193062870 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 Jednoczęściowe okularki do fototerapii by Sinmed Spółka Z Ograniczoną Odpowiedzialnością — Class I — MDR — listed in EUDAMED
Similar devices
Also classified as Phototherapy eye protector, reusable.
- NeoShades® with Headstrap Phototherapy Eye Shields - Micro Plain — Neotech Products LLC · Class I
- NeoShades® with Tabs Phototherapy Eye Shields - Small Plain — Neotech Products LLC · Class I
- Sahil Surgical (Pvt) Ltd — Sahil Surgical (Pvt) Ltd. · Class I
- PHOTOTHERAPY MASKS (Pack of 50) — GINEVRI srl · Class I
- EyeMax2 — Maxtec, Inc. · Class I
- WeeSpecs Supreme, Medium, 50/pk — INTERNATIONAL BIOMEDICAL, LTD. · Class I
- Phototherapy Eye Band Large — Dilamed Tıbbi Ürünler Sanayi ve Ticaret A.Ş. · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sinmed Spółka Z Ograniczoną Odpowiedzialnością
- EUDAMED SRN
- PL-MF-000002789
Sources (1)
- EUDAMED 60ac9d9d-ce26-4119-baa0-5f46a7fb83af 61 fields · synced Jun 20, 2026