Identity
- Trade Name
- Aquagel EUDAMEDFDA UDI
- Generic Name
- General-body orifice lubricant FDA UDI
- Device Name
- Aquagel Lubricating Gel EUDAMEDAQUAGEL LUBRICATING GEL 1/2 GAL BOTTLE FDA UDI
- Model / Reference
- 57-05 EUDAMED57-20 EUDAMEDLUBRICATING GEL FDA UDI
- Description
- AQUAGEL LUBRICATING GEL 1/2 GAL BOTTLE FDA UDI
Identifiers
- Catalog Number
- 57-20 FDA UDI
- Primary DI / UDI-DI
- 10855683006378 EUDAMED00855683006371 FDA UDI
- Basic UDI-DI
- 085568300657001KN EUDAMED
- 510(k) Number
- K864556 FDA UDI
- FDA Product Code
- KMJ FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- General-body orifice lubricant FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6375 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
Aquagel by Parker Laboratories, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 085568300657001KN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parker Laboratories, Inc.
- EUDAMED SRN
- US-MF-000013857
- Authorised Representative
- Parker Laboratories, BV NL-AR-000012618
Sources (2)
- EUDAMED 693a4b03-05ba-4313-a5ca-387ddd19ff60 61 fields · synced Jul 22, 2026
- FDA UDI 80d1df7e-40f1-4174-9dda-b167e3bcb92d 36 fields · synced May 30, 2026