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Polysonic Ultrasound Lotion
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 20-08Model 21-08
Identity
- Trade Name
- Polysonic Ultrasound Lotion EUDAMEDPOLYSONIC FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- Polysonic Ultrasound Lotion EUDAMEDPolysonic Ultrasound Lotion w/Aloe Vera, 250 ml bottle FDA UDI
- Model / Reference
- 21-08 EUDAMED20-08 EUDAMEDULTRASOUND LOTION W/ ALOE VERA FDA UDI
- Description
- Polysonic Ultrasound Lotion w/Aloe Vera, 250 ml bottle FDA UDI
Identifiers
- Catalog Number
- 20-08 FDA UDI
- Primary DI / UDI-DI
- 10855683006286 EUDAMEDFDA UDI
- Basic UDI-DI
- 085568300620021HA EUDAMED
- Unit of Use DI
- 00855683006289 EUDAMED
- FDA Product Code
- IYO 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
- 892.1560 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Polysonic Ultrasound Lotion by Parker Laboratories, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K827296 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 085568300620021HA | Class I | Active |
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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 535b7dec-a1d1-4639-a0ab-ecf7f28c0aef 61 fields · synced Jul 16, 2026
- FDA UDI 790cccfa-834d-4b9f-90ee-320417e4ffce 34 fields · synced May 30, 2026
- FDA 510(k) K827296 1 fields · synced May 18, 2026