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Bindex

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 2Model BI-2

by Bone Index Finland Oy

Identity

Trade Name
Bindex EUDAMEDFDA UDI
Generic Name
Bone absorptiometric ultrasound system FDA UDI
Device Name
Bindex EUDAMED
Model / Reference
BI-2 EUDAMEDFDA UDI
2 EUDAMED

Identifiers

Primary DI / UDI-DI
06430065790013 EUDAMEDFDA UDI
Basic UDI-DI
B-06430065790013 EUDAMED
FDA Product Code
MUA FDA UDI
EMDN Code
Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
GMDN Term
Bone absorptiometric ultrasound system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1180 FDA UDI
Market of Registration
Finland 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

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Bindex by Bone Index Finland Oy — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bone Index Finland Oy
EUDAMED SRN
FI-MF-000006812

Sources (2)

  • EUDAMED 082d3981-5ced-4757-9c5e-dfca4f6ffb2b 61 fields · synced Jul 23, 2026
  • FDA UDI 99f457fb-53a9-4198-acd5-a5877b0d5f1d 34 fields · synced May 30, 2026