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AquaCare
EUDAMEDClass IIa (EU MDR)
Ref I/MAC 8503FModel SingleRef I/MAC 8508FModel Twin (Black Edition)Ref I/MAC 8502FModel Twin
Identity
- Trade Name
- AquaCare EUDAMED
- Device Name
- AquaCare Dental Air Abrasion & Polishing Unit EUDAMED
- Model / Reference
- Single EUDAMEDI/MAC 8503F EUDAMEDTwin (Black Edition) EUDAMEDI/MAC 8508F EUDAMEDTwin EUDAMEDI/MAC 8502F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50602095800050 EUDAMED50602095800296 EUDAMED50602095800128 EUDAMED
- Basic UDI-DI
- B-50602095800050 EUDAMEDB-50602095800296 EUDAMEDB-50602095800128 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AquaCare by Medivance Instruments Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-50602095800050 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medivance Instruments Limited
- EUDAMED SRN
- GB-MF-000024293
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED c50f93ec-9202-40b4-9ee9-3a7bf265f932 61 fields · synced Aug 2, 2026
- EUDAMED 0b7ec5bd-5094-4ef6-b964-80de59e75a90 61 fields · synced May 18, 2026
- EUDAMED fc968b26-3c2d-4589-96be-2e1d1af32996 61 fields · synced May 18, 2026