Identity
- Trade Name
- Fastus Birthpack EUDAMED
- Device Name
- Sterile Procedure Pack EUDAMED
- Model / Reference
- 3040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060534891609 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
Fastus Birthpack 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 (1)
- EUDAMED 686bf3dd-5767-48a4-84f8-ba3df473a2f7 61 fields · synced Aug 5, 2026