Identity
- Trade Name
- LAPAROSCOPIC COLON PACK EUDAMED
- Device Name
- LAPAROSCOPIC COLON PACK EUDAMED
- Model / Reference
- CK8524 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10705036044529 EUDAMED
- Basic UDI-DI
- 0705031a028035D EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- LAPAROSCOPIC COLON EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Laparoscopic Colon Pack by Johnson & Johnson Medical S.p.a. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
- 3 POLI-SAFE 60X45 C/ ADESIVO — Linea Sterile S.p.A. · Class I
- CustomEyes® — Beaver-Visitec International, Inc. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- LAPAROSCOPIC COLON PACK — Johnson & Johnson Medical GmbH · Class III
- LAPAROSCOPIC SLEEVE RESECTION PACK — Johnson & Johnson Medical GmbH · Class III
- KIT GINECOLOGIA LAPAROSCOPIA — Linea Sterile S.p.A. · Class I
- SET 273 Ambulant — BATIST Medical Productions s.r.o. · Class III
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
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 | 0705031a028035D | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Johnson & Johnson Medical S.p.a.
- EUDAMED SRN
- IT-PR-000019349
Sources (1)
- EUDAMED 5be6ce90-7b14-403a-a93c-2ee9380a2788 61 fields · synced Oct 8, 2026