Identity
- Trade Name
- Tongue Tie Pack EUDAMEDTongue Tie Pack - Medium Gloves / No Tray EUDAMED
- Device Name
- Sterile Procedure Pack EUDAMED
- Model / Reference
- 5008 EUDAMED5008-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056745800479 EUDAMED05056745801926 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
Tongue Tie Pack by Clonallon Laboratories Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retractor/retraction system blade, single-use.
- AUTOMOTIVE KIT DIN13164-2022 in 2 PE bag — Bestreat Safety & First Aid Solution Co., Ltd. · Class I
- NEW DIN13169:2021 PLUS in GKB304 orange ABS box with two colors print, size: 38.5x27.2x13.8cm — Gauke Healthcare Co., Ltd · Class I
- First aid kits — Gauke Healthcare Co., Ltd · Class I
- BE COMBIKIT BLACK (Gdh+Vest+verbandset) — Hubei V-Medical Products Co.,Ltd. · Class I
- VERBANDDOOS LEGAAL JODIMA-ref 10.0046 compleet — Hubei V-Medical Products Co.,Ltd. · Class I
- Combi-bag PLUS FILLING, Shrink Foil pack-C3-2050 — Bestreat Safety & First Aid Solution Co., Ltd. · Class I
- PHARMACAR RED BAG — Bestreat Safety & First Aid Solution Co., Ltd. · Class I
- First aid kit DIN13157 — Gauke Healthcare Co., Ltd · 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 (2)
- EUDAMED dff56612-f8fb-4a2e-ae77-ad4bd97eb433 61 fields · synced Jul 31, 2026
- EUDAMED 018dbdea-fac3-4014-93d3-80ff9f8a0300 61 fields · synced May 17, 2026