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Sterile GOLFF antifog solution with sponge

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref G.O.L.F.F.

by Batrik Medical Manufacturing Inc.

Identity

Trade Name
G.O.L.F.F. Glasses or Lenses Fog Free FDA UDI
Generic Name
Endoscope antifog solution FDA UDI
Device Name
Sterile GOLFF antifog solution with sponge EUDAMED
Anti-Fog Solution Pouch with 6 g solution and adhesive sponge. FDA UDI
Model / Reference
G.O.L.F.F. EUDAMEDFDA UDI
Description
Anti-Fog Solution Pouch with 6 g solution and adhesive sponge. FDA UDI

Identifiers

Catalog Number
G.O.L.F.F. FDA UDI
Primary DI / UDI-DI
00690521013728 EUDAMEDFDA UDI
Basic UDI-DI
6905210GOLFF100RB EUDAMED
510(k) Number
K932449 FDA UDI
FDA Product Code
OCT FDA UDI
EMDN Code
K0180 ENDOTHERAPY DEVICES - OTHER ACCESSORIES EUDAMED
GMDN Term
Endoscope antifog solution FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Market of Registration
Malta EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Weight — 6 Gram FDA UDI

Sterile GOLFF antifog solution with sponge by Batrik Medical Manufacturing Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Batrik Medical Manufacturing Inc.
EUDAMED SRN
CA-MF-000007738
Authorised Representative
Advena Limited MT-AR-000000234

Sources (3)

  • EUDAMED ec0e25bf-7882-45ea-8322-fe78fc6fbbf5 61 fields · synced Jun 19, 2026
  • FDA UDI 07f7cb0a-189d-4870-bc31-b51f0094aaec 37 fields · synced May 30, 2026
  • FDA 510(k) K231822 1 fields · synced May 18, 2026