Identity
- Device Name
- Suction Tip EUDAMED
- Model / Reference
- ST1501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976475121004 EUDAMED
- Basic UDI-DI
- 697647512ST001NJ EUDAMED
- EMDN Code
- Z12119085 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - CONSUMABLES 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
Suction Tip by Changzhou Shengkang Medical Instrument 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 | 697647512ST001NJ | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Shengkang Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000035829
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED c84ecd9f-4bea-49a2-92e5-525286f1a075 61 fields · synced Oct 6, 2026