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Nbm200

FDA UDI

Class II (US FDA UDI)

by Orsense, Ltd.

Identity

Trade Name
NBM200 FDA UDI
Generic Name
Multiple physiological parameter spot-check system, clinical FDA UDI
Device Name
Non-Invasive Blood Hemoglobin (Hb) Measurement Monitor FDA UDI
Model / Reference
NBM7000 FDA UDI
Description
Non-Invasive Blood Hemoglobin (Hb) Measurement Monitor FDA UDI

Identifiers

Catalog Number
EU0241P FDA UDI
Primary DI / UDI-DI
17290013386011 FDA UDI
FDA Product Code
QGU FDA UDI
GMDN Term
Multiple physiological parameter spot-check system, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7500 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple physiological parameter spot-check system, clinical

Nbm200 by Orsense, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple physiological parameter spot-check system, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orsense, Ltd.

Sources (1)

  • FDA UDI 6e254ef4-aa58-455f-9d40-f5c5a39edb4c 35 fields · synced May 30, 2026