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stethoscope

EUDAMEDFDA UDI

Class I (EU MDR)

Ref BK3002Model BK3001, BK3002, BK3003, BK3005, BK3006, BK3007, BK3008, BK3009, BK3012

by Wenzhou Bokang Instruments Co., Ltd

Identity

Trade Name
stethoscope EUDAMED
BOKANG STETHOSCOPE FDA UDI
Generic Name
Mechanical external stethoscope FDA UDI
Device Name
stethoscope EUDAMED
BOKANG STETHOSCOPE is a manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. FDA UDI
Model / Reference
BK3001, BK3002, BK3003, BK3005, BK3006, BK3007, BK3008, BK3009, BK3012 EUDAMED
BK3002 EUDAMEDFDA UDI
Description
BOKANG STETHOSCOPE is a manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. FDA UDI

Identifiers

Primary DI / UDI-DI
06931038630027 EUDAMEDFDA UDI
Basic UDI-DI
69310386STE0001LZ EUDAMED
FDA Product Code
LDE FDA UDI
EMDN Code
C9005 PHONENDOSCOPES AND STETHOSCOPES EUDAMED
GMDN Term
Mechanical external stethoscope FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
870.1875 FDA UDI
Market of Registration
Italy 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

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

stethoscope by Wenzhou Bokang Instruments Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wenzhou Bokang Instruments Co., Ltd
EUDAMED SRN
CN-MF-000021505
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED 5126d6a8-4713-44a5-a6b3-9d920e90f967 61 fields · synced Jul 28, 2026
  • FDA UDI b0d322a0-611f-48b1-bef1-8230922e29cc 33 fields · synced May 30, 2026