Identity
- Trade Name
- UNO KIT 30 SMS 15X20 EUDAMED
- Device Name
- Agrupaciones Kits UNO EUDAMED
- Model / Reference
- UNO1520SMS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048320134 EUDAMED
- Basic UDI-DI
- 843404825KITUNOKC EUDAMED
- EMDN Code
- Z120611 VACUUM THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Procedure packs that bring together the devices needed for treatment with Negative Pressure Wound Therapy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Cupping therapy device
Uno Kit 30 Sms 15x20 by Prim S.a. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cupping therapy device.
- ACUDEPOT — Hansol Medical Co. · Class I
- Fascia Buddy Silicone Cups - Small — Eastern Currents Distributing Ltd · Class I
- Hansol Medical Co. — Hansol Medical Co. · Class I
- LymphaTouch — LymphaTouch Oy · Class IIa
- Vacuum cupping and Tools — TENS PLUS INDUSTRIAL COMPANY · Class I
- Safety Trap — ACARE TECHNOLOGY CO., LTD. · Class I
- GLASS CUP FLAT TOP NO.2 — TENS PLUS INDUSTRIAL COMPANY · Class I
- Tiger Warmer Large — Dong Bang Medical 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 | 843404825KITUNOKC | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-PR-000004648
Sources (1)
- EUDAMED 3f934479-4698-4fd4-9138-7a54ec39e83b 61 fields · synced Jul 8, 2026