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Aquasonic Clear Ultrasound Gel
EUDAMEDFDA UDIClass I (EU MDR)
Ref 03-34Model 01-08Ref 03-20
Identity
- Trade Name
- Aquasonic Clear Ultrasound Gel EUDAMEDAQUASONIC CLEAR FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- Aquasonic 100 Ultrasound Transmission Gel EUDAMEDAquasonic Clear Ultrasound Gel, 1 Liter bottle FDA UDI
- Model / Reference
- 01-08 EUDAMED03-34 EUDAMED03-20 EUDAMEDULTRASOUND GEL FDA UDI
- Description
- Aquasonic Clear Ultrasound Gel, 1 Liter bottle FDA UDI
Identifiers
- Catalog Number
- 03-34 FDA UDI
- Primary DI / UDI-DI
- 10855683006101 EUDAMEDFDA UDI20855683006702 EUDAMED
- Basic UDI-DI
- 085568300601003GR EUDAMED
- Unit of Use DI
- 00855683006104 EUDAMED00855683006708 EUDAMED
- FDA Product Code
- MUI FDA UDI
- EMDN Code
- Z11049085 VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Electrode conductive medium FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Aquasonic Clear Ultrasound Gel by Parker Laboratories, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 085568300601003GR | 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 (3)
- EUDAMED cc59f14f-861e-49a9-a10b-10988497208b 61 fields · synced Jul 16, 2026
- EUDAMED 69a4606e-32f6-4d3c-8444-8045098efc99 61 fields · synced May 19, 2026
- FDA UDI 4108baf1-9472-4dff-9462-6a521ee08611 35 fields · synced May 30, 2026