Identity
- Trade Name
- Ergo 3 EUDAMED
- Device Name
- Ergo Lite EUDAMED
- Model / Reference
- ERG LITE (KM-2501) EUDAMED110400001360 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892870481 EUDAMED
- Basic UDI-DI
- 471987385ErgoXT EUDAMED
- Direct Marketing DI
- 04719892870481 EUDAMED
- EMDN Code
- Y122103,Y122106 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Ergo 3 by Karma Medical Products Co., Ltd. — 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 | 471987385ErgoXT | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Karma Medical Products Co., Ltd
- EUDAMED SRN
- TW-MF-000013206
- Authorised Representative
- KARMA MOBILITY S.L. ES-AR-000004852
Sources (1)
- EUDAMED 46b4b9a0-8702-4b9b-afd4-c24ac557d8e4 61 fields · synced Oct 7, 2026