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Probe, Temp, Mr411, Eso/Rect, Aud
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MR411(0011-30-90446)Model MR404B(0011-30-37408)/MR404B(0011-30-37395)/MR404B(040-003739-00)/MR404B(125-000144-00)/MR403BS(125-000764-00)/MR412(040-011543-00)/MR412(040-011544-00)/MR412(040-011548-00)/MR412(0011-30-90447)/MR412(0011-30-90439)/MR412(115-047684-00)
Identity
- Trade Name
- Temperature probe EUDAMEDPROBE,TEMP,MR411,ESO/RECT,AUD FDA UDI
- Generic Name
- General-purpose patient temperature probe, reusable FDA UDI
- Device Name
- Temperature probe EUDAMED
- Model / Reference
- MR404B(0011-30-37408)/MR404B(0011-30-37395)/MR404B(040-003739-00)/MR404B(125-000144-00)/MR403BS(125-000764-00)/MR412(040-011543-00)/MR412(040-011544-00)/MR412(040-011548-00)/MR412(0011-30-90447)/MR412(0011-30-90439)/MR412(115-047684-00) EUDAMEDMR411(0011-30-90446) EUDAMED0011-30-90446 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904005218 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449040AB010000513F EUDAMED
- 510(k) Number
- K143195 FDA UDI
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMED
- GMDN Term
- General-purpose patient temperature probe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: General-purpose patient temperature probe, reusable
Probe, Temp, Mr411, Eso/Rect, Aud by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as General-purpose patient temperature probe, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- TRUWAVE — Edwards Lifesciences LLC · Class II
- MED-LINK — Shenzhen Med-Link Electronics Tech Co., Ltd. · Class II
- LIFEPAK 15 monitor/defibrillator — PHYSIO-CONTROL, Inc.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K143195 also covers:
- 12-Lead Leadset, Chest, AHA, Clip — Shenzhen Mindray Bio-Medical Electronics Co.
- 12-Lead Leadset, Chest, AHA, Snap — Shenzhen Mindray Bio-Medical Electronics Co.
- 12Pin 3-Lead ECG Cable, AHA, Clip — Shenzhen Mindray Bio-Medical Electronics Co.
- 12Pin 3-Lead ECG Cable, AHA, Snap — Shenzhen Mindray Bio-Medical Electronics Co.
- 12Pin 3-Lead ECG Host Cable, Def-P — Shenzhen Mindray Bio-Medical Electronics Co.
- 12Pin 3-Lead Host Cable, Def-P, DIN Conn — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-LEAD, ECG, UNIV, SNAP, 18", USA — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-LEAD, ECG, UNIV, SNAP, 36", AAMI — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead Leadset, Adt/Ped, AHA, Clip — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead Leadset, Inf, AHA, Snap — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, ECG, Univ, Pinch, 24", AAMI — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, ECG, Univ, Pinch, 24", IEC — Shenzhen Mindray Bio-Medical Electronics Co.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 4fea592e-02a7-42b0-84f6-69f506c812a0 34 fields · synced Jul 31, 2026
- EUDAMED b6c213dc-8bb2-4a02-bb81-7b76f87b1830 61 fields · synced Jul 31, 2026