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Bindex BI-2 Kit

FDA UDIFDA 510(k)

Class II (US FDA UDI)

510(k) K211350

by Bone Index Finland , Ltd.

Identity

Trade Name
Bindex BI-2 Kit FDA UDI
Generic Name
Bone absorptiometric ultrasound system FDA UDI
Device Name
Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41. FDA UDI
Model / Reference
v3 (w/o Gel) FDA UDI
Description
Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41. FDA UDI

Identifiers

Primary DI / UDI-DI
06430065790051 FDA UDI
FDA Product Code
MUA FDA UDI
GMDN Term
Bone absorptiometric ultrasound system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1180 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Bone absorptiometric ultrasound system

Bindex BI-2 Kit by Bone Index Finland , Ltd. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Bone absorptiometric ultrasound system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bone Index Finland , Ltd.

Sources (2)

  • FDA UDI dc801378-22b3-4949-b98b-6941c33f203a 59 fields · synced Jun 18, 2026
  • FDA 510(k) K161971 1 fields · synced Jun 5, 2026