Identity
- Device Name
- Aplicator Tips EUDAMED
- Model / Reference
- S1 H1 H2 H3 EUDAMEDH1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978043130395 EUDAMED
- Basic UDI-DI
- 697804313AplicatorTipsLK EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER 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
Aplicator Tips by Suzhou Puruiang biotechnology co., Itd — 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 | 697804313AplicatorTipsLK | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Puruiang biotechnology co., Itd
- EUDAMED SRN
- CN-MF-000054162
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e074a64b-dd66-45db-acfa-2497c2acde75 61 fields · synced Jun 14, 2026