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Spreaders
EUDAMEDClass I (EU MDR)
Ref J330 650 982 3102 080Model Pluggers(SS304)、Spreaders(SS304)
Identity
- Trade Name
- Spreaders EUDAMED
- Device Name
- Dental Root-Canal Instruments EUDAMED
- Model / Reference
- Pluggers(SS304)、Spreaders(SS304) EUDAMEDJ330 650 982 3102 080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942200955473 EUDAMED
- Basic UDI-DI
- 697590932SSTCompactorS9 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE 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
Spreaders by Shanwei Perfect Medical Instruments 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 | 697590932SSTCompactorS9 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanwei Perfect Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000033003
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 41fae5a5-a720-404e-bcdb-41e8efc20885 61 fields · synced Aug 1, 2026