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Sodium Bicarbonate Powder (White label)
EUDAMEDClass I (EU MDR)
Ref I/PDR 8014F
Identity
- Trade Name
- Sodium Bicarbonate Powder (White label) EUDAMED
- Device Name
- Dental Air Abrasion Powders EUDAMED
- Model / Reference
- I/PDR 8014F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50602095801590 EUDAMED
- Basic UDI-DI
- 506020958PowdersCIJP EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS 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
Sodium Bicarbonate Powder (White label) 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 | 506020958PowdersCIJP | Class I | 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 f6be84f1-61cc-45ca-ae4a-05bc9022c439 61 fields · synced Jun 18, 2026