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Irrigation Needle
EUDAMEDClass I (EU MDR)
Ref TINE.27.25.1HModel TiaEndo Irrigation Needles: TIN.27.25.2H, TIN.30.25.2HTiaEndo Irrigation Needles Elite: TINE.27.25.2H, TINE.30.25.2H, TINE.27.25.1H, TINE.30.25.1H, TIN.27.25.1H, TIN.30.25.1H
by TiaDent Inc
Identity
- Device Name
- Irrigation Needle EUDAMED
- Model / Reference
- TiaEndo Irrigation Needles: TIN.27.25.2H, TIN.30.25.2HTiaEndo Irrigation Needles Elite: TINE.27.25.2H, TINE.30.25.2H, TINE.27.25.1H, TINE.30.25.1H, TIN.27.25.1H, TIN.30.25.1H EUDAMEDTINE.27.25.1H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810193174750 EUDAMED
- Basic UDI-DI
- 081019026TINBW EUDAMED
- EMDN Code
- A010602 DENTAL IRRIGATION NEEDLES 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 by TiaDent Inc — 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 | 081019026TINBW | Class I | Active |
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Manufacturer
- Manufacturer
- TiaDent Inc
- EUDAMED SRN
- US-MF-000049704
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e2488af6-31e2-4365-8dff-7665dd885a36 61 fields · synced Jun 17, 2026