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SmartTemp Probe Cover
EUDAMEDClass I (EU MDR)
Ref ST-001(M09A-30-62128)Model ST-001(M09A-20-62124)/ST-001(M09A-30-62126)/ST-001(M09A-30-62128)/MR491(M09A-20-62062)/MR492(M09A-20-62062-51)
Identity
- Trade Name
- SmartTemp Probe Cover EUDAMED
- Device Name
- Temp probe cover EUDAMED
- Model / Reference
- ST-001(M09A-20-62124)/ST-001(M09A-30-62126)/ST-001(M09A-30-62128)/MR491(M09A-20-62062)/MR492(M09A-20-62062-51) EUDAMEDST-001(M09A-30-62128) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904007908 EUDAMED
- Basic UDI-DI
- 69449040AB010000433G EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SmartTemp Probe Cover by Shenzhen Mindray Bio-Medical Electronics 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 | 69449040AB010000433G | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 406dee7d-c7a7-4e30-8360-251001951555 61 fields · synced Jun 19, 2026