Identity
- Device Name
- Dilator [Long Taper] EUDAMED
- Model / Reference
- JCD22.0-38-20-LTD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00827002609945 EUDAMED
- Basic UDI-DI
- 0827002CINC014-031_AHD EUDAMED
- EMDN Code
- C9002 VASCULAR AND FASCIAL DILATORS 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
Category: Fascial tissue dilator, single-use
Dilator [Long Taper] by Cook Incorporated — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fascial tissue dilator, single-use.
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- Vessel Dilator — Argon Medical Devices, Inc. · Class II
- Evolution — COOK VANDERGRIFT INC. · Class II
- VisiSheath Dilator Sheath — Spectranetics Corporation · Class III
- Byrd — COOK VANDERGRIFT INC. · Class I
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 | 0827002CINC014-031_AHD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cook Incorporated
- EUDAMED SRN
- US-MF-000003180
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (1)
- EUDAMED 3c9626db-1df1-4105-a246-004b8fd53363 61 fields · synced Jul 15, 2026