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Silicone Polishers
EUDAMEDClass I (EU MDR)
Ref SH-3212 (RA) Coarse,Cup,9.5*8mm,ISO:030 095 ，12pcs/boxModel SK-2142 ，SK-2021，SK-2022，SH-3113, SH-3203, SH-3413,SH-3133,SH-3114, SH-3204, SH-3115, SH-3205
Identity
- Trade Name
- Silicone Polishers EUDAMED
- Device Name
- Polishers EUDAMED
- Model / Reference
- SK-2142 ，SK-2021，SK-2022，SH-3113, SH-3203, SH-3413,SH-3133,SH-3114, SH-3204, SH-3115, SH-3205 EUDAMEDSH-3212 (RA) Coarse,Cup,9.5*8mm,ISO:030 095 ，12pcs/box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977493108824 EUDAMED
- Basic UDI-DI
- 697749310010032V9 EUDAMED
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Category: Carbide dental bur, single-use
Silicone Polishers by Shanghai Dochem Industries Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697749310010032V9 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Dochem Industries Co., Ltd.
- EUDAMED SRN
- CN-MF-000014350
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 271d391b-adc2-4959-8a1a-0d0f15300594-1 61 fields · synced Jun 19, 2026
- EUDAMED 271d391b-adc2-4959-8a1a-0d0f15300594-2 61 fields · synced Jun 19, 2026