Identity
- Trade Name
- SOFT KIT COMPACT EUDAMED
- Device Name
- SOFT KIT COMPACT EUDAMED
- Model / Reference
- KL-10040/KL-10041/KL-10042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942272600400 EUDAMED
- Basic UDI-DI
- 69422726J1.02.03SK EUDAMED
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Elastic Bandage,5*450cm（Gasbinda） Elastic Bandage,7.5*450cm（Gasbinda） Adhesive Plasters（Textile）,72*19mm（Textilplåsters） Adhesive Plasters（Kids）,72*19mm（Barnplåsters） Medical Tape（Papperstejp） Cotton Swabs（Bomullspinne） Gauze Sponges,2”x2”（Kompresser） Gauze Sponges,3”x3”（Kompresser） Burn Cream（Brännskadecreme） Scissors（Sax） Instruction Manual（BRUKSANVISNING） EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Soft Kit Compact by Firstar Healthcare Company Limited (guangzhou) — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69422726J1.02.03SK | Class I | Active |
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Manufacturer
- Manufacturer
- Firstar Healthcare Company Limited (guangzhou)
- EUDAMED SRN
- CN-PR-000037943
Sources (1)
- EUDAMED c09752e9-5673-4f53-a0d2-c50c89cdbc12 61 fields · synced Oct 6, 2026