Identity
- Trade Name
- AB13 Sterile Umbilical Scissors EUDAMED
- Device Name
- Sterile Procedure Pack EUDAMED
- Model / Reference
- AB13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060534899438 EUDAMED
- Basic UDI-DI
- 5060534890008VK EUDAMED
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Non-Specialist Surgical Instruments and Kits, Single-Use EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Cranial bur, single-use
AB13 Sterile Umbilical Scissors by Clonallon Laboratories Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cranial bur, single-use.
- HiCUT Burs — adeor Medical AG · Class II
- Disposable Sterile Vessel Punch — Zibo MK Medical Technology Co., Ltd. · Class IIa
- PDS-2RDUL-15 — NAKANISHI INC. · Class IIa
- GT PODO 7 mm spitz/pointed Schaft 2, 35 X 40 — LUKAS-ERZETT GmbH & Co.KG · Class I
- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- J-Notch Burs — Stryker Instruments · Class IIa
- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- GT PODO 5 mm rund/round Schaft 2, 35 x 35 — LUKAS-ERZETT GmbH & Co.KG · 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 | 5060534890008VK | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clonallon Laboratories Ltd
- EUDAMED SRN
- XI-PR-000033753
Sources (1)
- EUDAMED 8b088612-99cf-47e3-b705-6a17e40bf441 61 fields · synced Jul 30, 2026