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EchoTip Insight® Endoscopic Ultrasound Needle
EUDAMEDClass IIa (EU MDR)
Ref ECHO-PPG-25-I
Identity
- Device Name
- EchoTip Insight® Endoscopic Ultrasound Needle EUDAMED
- Model / Reference
- ECHO-PPG-25-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00827002579996 EUDAMED
- Basic UDI-DI
- 0827002CIRL202007060005CF EUDAMED
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
EchoTip Insight® Endoscopic Ultrasound Needle by Cook Ireland Limited — Class IIa — 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 | 0827002CIRL202007060005CF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cook Ireland Limited
- EUDAMED SRN
- IE-MF-000001530
Sources (1)
- EUDAMED c4d4e1d9-4894-4d30-b2b5-d133359379c1 61 fields · synced Jun 19, 2026