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Polishing Kits
EUDAMEDClass I (EU MDR)
Ref PK91BModel PK91B，PK81B，PK71B，PK11B，PK61B，PK31B，PK101B，PK21B，PK004，WK02，PK005，RA0309，PK020，PK010，WK01X，PK006，PK02X，RA0509，PK03X，PK04X，PK001
Identity
- Device Name
- Polishing Kits EUDAMED
- Model / Reference
- PK91B，PK81B，PK71B，PK11B，PK61B，PK31B，PK101B，PK21B，PK004，WK02，PK005，RA0309，PK020，PK010，WK01X，PK006，PK02X，RA0509，PK03X，PK04X，PK001 EUDAMEDPK91B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978315817009 EUDAMED
- Basic UDI-DI
- 697831581PolishingkitsTR EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Lithuania 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
Polishing Kits by Wuxi Weller Technology 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 | 697831581PolishingkitsTR | Class I | Active |
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Manufacturer
- Manufacturer
- Wuxi Weller Technology Co., LTD
- EUDAMED SRN
- CN-MF-000046706
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 3fcb067a-abcd-40f8-a0bc-4881757ddebf 61 fields · synced Jul 23, 2026