Identity
- Trade Name
- EchoTip ClearCore EUDAMEDFDA UDI
- Generic Name
- Ultrasound aspiration biopsy procedure kit FDA UDI
- Device Name
- EchoTip AcuCore EUS Biopsy Needle EUDAMEDEchotip ClearCore EUS Biopsy Needle FDA UDI
- Model / Reference
- ECHO-BX-19 EUDAMEDG59742 FDA UDI
- Description
- Echotip ClearCore EUS Biopsy Needle FDA UDI
Identifiers
- Catalog Number
- ECHO-BX-19 FDA UDI
- Primary DI / UDI-DI
- 00827002597426 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002CIRL202011039025AY EUDAMED
- FDA Product Code
- FCG FDA UDI
- EMDN Code
- A01020102 ASPIRATION FINE NEEDLES AND KITS EUDAMED
- GMDN Term
- Ultrasound aspiration biopsy procedure kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diskectomy system, percutaneous, automatic
EchoTip ClearCore by Cook Ireland Limited — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diskectomy system, percutaneous, automatic.
- Biopsy Needle — Argon Medical Devices, Inc. · Class IIa
- INTRODUTTORE — BIOPSYBELL SRL · Class IIa
- CHIBELL CON SIRINGA — BIOPSYBELL SRL · Class IIa
- CHIBELL — BIOPSYBELL SRL · Class IIa
- Biopsy Needle — Argon Medical Devices, Inc. · Class IIa
- 0ME2320 — Biomedical S.r.l. · Class IIa
- 0ME1810 — Biomedical S.r.l. · Class IIa
- DISKIT — BIOPSYBELL SRL · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0827002CIRL202011039025AY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Cook Ireland Limited
- EUDAMED SRN
- IE-MF-000001530
Sources (2)
- EUDAMED 997b7a6b-4887-4a54-845e-0aff2d9bd1cb 61 fields · synced Jul 18, 2026
- FDA UDI 07e6ee60-5e58-4f69-a8e1-b9df31241e2a 36 fields · synced May 30, 2026