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Disposable prophy brush
EUDAMEDClass I (EU MDR)
Ref #PBB01Model #PBB01 #PBT02 #PBB02 #PBF02 #PBFM01 #PBF01 #PBT01 #PBCF03 #PBCT01 #PBC01 #PA01
Identity
- Device Name
- Disposable prophy brush EUDAMED
- Model / Reference
- #PBB01 #PBT02 #PBB02 #PBF02 #PBFM01 #PBF01 #PBT01 #PBCF03 #PBCT01 #PBC01 #PA01 EUDAMED#PBB01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977522400004 EUDAMED
- Basic UDI-DI
- 697752240DPBEU01RZ EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Disposable prophy brush by Shanghai Lions Industrial Co., Ltd — 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 | 697752240DPBEU01RZ | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Lions Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000041956
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6cfa1849-e0c0-4294-ad6b-4ef8eef261fa 61 fields · synced Jul 9, 2026