← Back to catalogue
Klarity SGRT System
EUDAMEDClass IIb (EU MDR)
Ref ARSG-E1AModel ARSG-E1A, ARSG-E3A
Identity
- Device Name
- Klarity SGRT System EUDAMED
- Model / Reference
- ARSG-E1A, ARSG-E3A EUDAMEDARSG-E1A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06920824156094 EUDAMED
- Basic UDI-DI
- 692082412500CT EUDAMED
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Klarity SGRT System by Klarity Medical & Equipment（GZ） Co., Ltd. — Class IIb — 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 | 692082412500CT | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Klarity Medical & Equipment（GZ） Co., Ltd.
- EUDAMED SRN
- CN-MF-000002229
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 05731fb4-48c1-4566-9348-814056eb850b 61 fields · synced Oct 5, 2026