Identity
- Trade Name
- Medicare First Aid Home Kit EUDAMED
- Device Name
- First Aid Kit EUDAMED
- Model / Reference
- MD6004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05099390413489 EUDAMED
- Basic UDI-DI
- 5099390FAKit4U EUDAMED
- Direct Marketing DI
- 05099390413489 EUDAMED
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Surgical retractor/retraction system blade, single-use
Medicare First Aid Home Kit by Fleming Medical — Class IIb — 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
- Coil Pack - Essentials — Clonallon Laboratories 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 | 5099390FAKit4U | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fleming Medical
- EUDAMED SRN
- IE-MF-000044303
Sources (1)
- EUDAMED 18472a7f-2228-450a-b30d-e12ac3b17efb 61 fields · synced Jun 20, 2026