Identity
- Trade Name
- Dental Irrigation Needles EUDAMED
- Device Name
- Dental Irrigation Needles EUDAMED
- Model / Reference
- 0502 EUDAMED0504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973158630075 EUDAMED
- Basic UDI-DI
- 697315863DNTS00001KE EUDAMED
- EMDN Code
- A010602 DENTAL IRRIGATION NEEDLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Dental Irrigation Needles by iBrite Suzhou 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 | 697315863DNTS00001KE | Class I | Active |
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Manufacturer
- Manufacturer
- iBrite Suzhou Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000022047
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED df00e7de-372a-4ee3-9cb9-70a510190a47 61 fields · synced Jun 18, 2026