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Santamedical

FDA UDI

Class II (US FDA UDI)

by Shanghai Berry Electronic Tech Co., Ltd.

Identity

Trade Name
SANTAMEDICAL FDA UDI
Generic Name
Pulse oximeter FDA UDI
Device Name
Fingertip Pulse Oximeter FDA UDI
Model / Reference
SM-519BR-BL FDA UDI
Description
Fingertip Pulse Oximeter FDA UDI

Identifiers

Primary DI / UDI-DI
06924054300005 FDA UDI
FDA Product Code
OCH FDA UDI
GMDN Term
Pulse oximeter 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

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Pulse oximeter

Santamedical by Shanghai Berry Electronic Tech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shanghai Berry Electronic Tech Co., Ltd.

Sources (1)

  • FDA UDI 4f11cd9f-fa12-415f-8145-3572a20d1109 34 fields · synced May 30, 2026