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Irrigation Needle Tip
EUDAMEDClass I (EU MDR)
Ref 18GModel 18G、20G、22G、25G、27G, 30G,0325、0425、0525、0625、0.35、0.25
Identity
- Device Name
- Irrigation Needle Tip EUDAMED
- Model / Reference
- 18G、20G、22G、25G、27G, 30G,0325、0425、0525、0625、0.35、0.25 EUDAMED18G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975336240786 EUDAMED
- Basic UDI-DI
- 697533624INT001L7 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - 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
Irrigation Needle Tip by Rocodent International Limited — 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 | 697533624INT001L7 | Class I | Active |
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Manufacturer
- Manufacturer
- Rocodent International Limited
- EUDAMED SRN
- CN-MF-000045441
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a8607fa8-182b-43da-b432-71edd3405af3 61 fields · synced Jul 26, 2026