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Sterile GOLFF R1 antifog solution with sponge
EUDAMEDClass IIa (EU MDR)
Ref GOLFF-R1 Ref GOLFF-R1
Identity
- Device Name
- Sterile GOLFF R1 antifog solution with sponge EUDAMEDGOLFF-R1 Sterile Anti-Fog Solution EUDAMED
- Model / Reference
- GOLFF-R1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00690521019072 EUDAMED
- Basic UDI-DI
- 6905210GOLFFR1100JY EUDAMED
- EMDN Code
- K0180 ENDOTHERAPY DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile GOLFF R1 antifog solution with sponge by Batrik Medical Manufacturing Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6905210GOLFFR1100JY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 56466aea-1d96-4d18-8e63-5acb9db5eb76 61 fields · synced Jul 26, 2026
- EUDAMED 106b78db-786c-456a-a165-91f789459144 61 fields · synced Jul 26, 2026