Identity
- Trade Name
- Logiscan Clear EUDAMED
- Device Name
- Aquasonic 100 Ultrasound Transmission Gel EUDAMED
- Model / Reference
- 01-08 EUDAMEDMLLSC25 EUDAMEDMLLSC50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10855683006781 EUDAMED10855683006811 EUDAMED
- Basic UDI-DI
- 085568300601003GR EUDAMED
- Unit of Use DI
- 00855683006784 EUDAMED00855683006814 EUDAMED
- EMDN Code
- Z11049085 VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Logiscan Clear by Parker Laboratories, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 085568300601003GR | 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 (2)
- EUDAMED 0849d518-7fba-42f5-970a-4c2413252440 61 fields · synced Jun 20, 2026
- EUDAMED b7703eab-f191-48a7-9392-d6c2b899a187 61 fields · synced May 18, 2026