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Caremed

FDA UDI

Class II (US FDA UDI)

by Shenzhen Caremed Medical Technology Co., Ltd.

Identity

Trade Name
Caremed FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
Caremed Reusable SpO2 Sensors FDA UDI
Model / Reference
Reusable FDA UDI
Description
Caremed Reusable SpO2 Sensors FDA UDI

Identifiers

Primary DI / UDI-DI
06970758500029 FDA UDI
510(k) Number
K153184 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Pulse oximeter probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulse oximeter probe, reusable

Caremed by Shenzhen Caremed Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter probe, reusable.

Cleared under the same submission

K153184 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Caremed Medical Technology Co., Ltd.

Sources (1)

  • FDA UDI 85b55227-0f5e-44e5-899f-aed8ca83af14 34 fields · synced Jun 8, 2026