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Irrigation Needle
EUDAMEDClass I (EU MDR)
Ref 21G-RWPModel Type P、Type D、Type S
Identity
- Trade Name
- Irrigation Needle EUDAMEDGlide Flow EUDAMED
- Device Name
- lrrigation Needle EUDAMED
- Model / Reference
- Type P、Type D、Type S EUDAMED21G-RWP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942200926459 EUDAMED
- Basic UDI-DI
- 69422009IrriNeedleLS EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDGermany 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
Irrigation Needle 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 | 69422009IrriNeedleLS | 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 (2)
- EUDAMED 62590558-89a1-4a43-b432-fb4f1f4ff879 61 fields · synced Jun 17, 2026
- EUDAMED 073008bc-ec23-4df9-8a2b-1f23573a2ee1 61 fields · synced Jun 11, 2026