Identity
- Trade Name
- Coil Pack - Standard EUDAMEDCoil Pack EUDAMED
- Device Name
- Sterile Procedure Pack EUDAMED
- Model / Reference
- 3455 EUDAMED3136B EUDAMED3451 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060534892774 EUDAMED05060534891487 EUDAMED05060534890336 EUDAMED
- Basic UDI-DI
- 5060534890008VK EUDAMED
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Non-Specialist Surgical Instruments and Kits, Single-Use EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Surgical retractor/retraction system blade, single-use
Coil Pack - Standard by Clonallon Laboratories Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical retractor/retraction system blade, single-use.
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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 | 5060534890008VK | Class I | Active |
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Manufacturer
- Manufacturer
- Clonallon Laboratories Ltd
- EUDAMED SRN
- XI-PR-000033753
Sources (3)
- EUDAMED e204eafe-937e-498b-ad27-c4f06193de83 61 fields · synced Jul 13, 2026
- EUDAMED 7bb04a9b-c54b-42c4-b26d-ea67ce727a55 61 fields · synced May 18, 2026
- EUDAMED c22d2eb1-f8b2-4b5a-89e1-d6e8ce533428 61 fields · synced May 18, 2026