Identity
- Trade Name
- Aquaflex Ultrasound Gel Pad EUDAMED
- Device Name
- Aquaflex Gel Pad EUDAMED
- Model / Reference
- 04-02 EUDAMED04-40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10855683006842 EUDAMED
- Basic UDI-DI
- 085568300604000H8 EUDAMED
- Unit of Use DI
- 00855683006845 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
Aquaflex Ultrasound Gel Pad 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 | 085568300604000H8 | 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 (1)
- EUDAMED 13e94b70-6d1a-4a88-af6d-f3cde57c56c1 61 fields · synced Jun 19, 2026