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Aluminium Oxide 53 µm Powder (Red label)
EUDAMEDClass IIa (EU MDR)
Ref I/PDR 8024F
Identity
- Trade Name
- Aluminium Oxide 53 µm Powder (Red label) EUDAMED
- Device Name
- Dental Air Abrasion Powder EUDAMED
- Model / Reference
- I/PDR 8024F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50602095801422 EUDAMED
- Basic UDI-DI
- 506020958ACPowdersA9 EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS 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
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
Aluminium Oxide 53 µm Powder (Red label) by Medivance Instruments Limited — Class IIa — 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 | 506020958ACPowdersA9 | 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 (1)
- EUDAMED 83d78023-44d6-4be2-81e3-7ce7ba388782 61 fields · synced Jul 9, 2026