Covers, Temp Probe
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- SmartTemp Probe Cover EUDAMEDCOVERS,TEMP PROBE FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- 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-20-62124) EUDAMEDM09A-20-62124 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904007892 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449040AB010000433G EUDAMED
- 510(k) Number
- K170712 FDA UDI
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: General-purpose multi-parameter bedside monitor
Covers, Temp Probe by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (2)
- FDA UDI b41f0e47-58ce-4b07-bb8b-b72754e7b175 34 fields · synced Jun 18, 2026
- EUDAMED 99b1174d-2e8d-420b-bbda-966c94364255 61 fields · synced Jun 18, 2026