Identity
- Trade Name
- DEFOGGER Anti Fog Kit EUDAMEDDeRoyal FDA UDI
- Generic Name
- Endoscope antifog solution FDA UDI
- Device Name
- DEFOGGER Anti Fog Kit EUDAMEDDEFOGGER!" Anti Fog Kit FDA UDI
- Model / Reference
- 28-0101B EUDAMEDFDA UDI
- Description
- DEFOGGER!" Anti Fog Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00749756301749 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00749756301749 EUDAMED
- FDA Product Code
- OCT FDA UDI
- EMDN Code
- Z12021199 ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Endoscope antifog solution FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands 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
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
Prescription Use
No
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
Category: Rigid endoscope obturator
DEFOGGER Anti Fog Kit by Deroyal Industries, Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982465 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00749756301749 | Class IIa | Active |
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Manufacturer
- Manufacturer
- DeRoyal Industries, Inc.
- EUDAMED SRN
- US-MF-000002102
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (3)
- EUDAMED 53a5ed88-ca7d-4aaa-a9ef-f85facc51cf1 61 fields · synced Jul 11, 2026
- FDA UDI e019e04c-a6a7-4d77-b233-fee9d1ef9bcd 34 fields · synced May 30, 2026
- FDA 510(k) K982465 1 fields · synced May 18, 2026