Identity
- Trade Name
- Irrigation Needle for Single Use EUDAMED
- Device Name
- Irrigation Needle for Single Use EUDAMED
- Model / Reference
- D12140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949236213089 EUDAMED
- Basic UDI-DI
- 69492362N008QU EUDAMED
- EMDN Code
- A010602 DENTAL IRRIGATION NEEDLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Irrigation Needle for Single Use by Berpu Medical 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 | 69492362N008QU | Class I | Active |
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Manufacturer
- Manufacturer
- Berpu Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000012430
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 05fd1287-9383-4ecc-895b-fc17abcaac1a 61 fields · synced Jun 19, 2026