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Bc-1

FDA UDIEUDAMED

Class II (US FDA UDI)

by Bhm-Tech Produktionsgesellschaft Mbh

Identity

Trade Name
BC-1 FDA UDI
Generic Name
Auditory cranial bone vibrator FDA UDI
Device Name
Audiometric receiver with headband FDA UDI
Model / Reference
BC-1-BONE-W-HEADBAND FDA UDI
Description
Audiometric receiver with headband FDA UDI

Identifiers

Catalog Number
77735020 FDA UDI
Primary DI / UDI-DI
09120041051500 FDA UDI
510(k) Number
K102199 FDA UDI
FDA Product Code
LXB FDA UDI
GMDN Term
Auditory cranial bone vibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3302 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Auditory cranial bone vibrator

Bc-1 by Bhm-Tech Produktionsgesellschaft Mbh — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Auditory cranial bone vibrator.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bhm-Tech Produktionsgesellschaft Mbh

Sources (2)

  • FDA UDI 7b567b40-11db-431c-ba7f-145c55ebf281 37 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026