Identity
- Trade Name
- Ergo Foot Pedal Assembly EUDAMED
- Device Name
- AquaCare Components EUDAMED
- Model / Reference
- I/ASS 9700F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50602095803648 EUDAMED
- Basic UDI-DI
- 506020958AquaCareCIWF EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Ergo Foot Pedal Assembly by Medivance Instruments Limited — 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 | 506020958AquaCareCIWF | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medivance Instruments Limited
- EUDAMED SRN
- GB-MF-000024293
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 42feaf5c-1a89-4eff-9630-42675236a5de 61 fields · synced Jun 18, 2026