Identity
- Trade Name
- Logiscan Blue EUDAMED
- Device Name
- Aquasonic 100 Ultrasound Transmission Gel EUDAMED
- Model / Reference
- 01-08 EUDAMEDMLLSB50 EUDAMEDMLLSB25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10855683006798 EUDAMED10855683006767 EUDAMED
- Basic UDI-DI
- 085568300601003GR EUDAMED
- Unit of Use DI
- 00855683006791 EUDAMED00855683006760 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 Blue 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 0b4b647d-4f86-4918-a71f-3b357c06c2c0 61 fields · synced Jun 20, 2026
- EUDAMED 2ef7548b-a8b3-45dc-8506-41dbf2bb62e0 61 fields · synced May 18, 2026