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BD Intermittent Catheter

EUDAMEDFDA UDI

Class I (EU MDR)

Ref BUC14C

by Hangzhou Bever Medical Devices Co., Ltd.

Identity

Trade Name
BD Intermittent Catheter EUDAMED
BD Intermittent FDA UDI
Generic Name
Single-administration urethral drainage catheter FDA UDI
Device Name
Intermittent Catheter EUDAMED
BD Intermittent Catheter FDA UDI
Model / Reference
BUC14C EUDAMEDFDA UDI
Description
BD Intermittent Catheter FDA UDI

Identifiers

Catalog Number
BUC14C FDA UDI
Primary DI / UDI-DI
06948796203875 EUDAMEDFDA UDI
Basic UDI-DI
69487962TC0001SJ EUDAMED
510(k) Number
K111405 FDA UDI
FDA Product Code
GBM FDA UDI
EMDN Code
U01010602 TIEMANN CATHETERS, NON SELF-LUBRICATING EUDAMED
GMDN Term
Single-administration urethral drainage catheter FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
Market of Registration
Poland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 14 French FDA UDI
Catheter Length — 16 Inch FDA UDI

BD Intermittent Catheter by Hangzhou Bever Medical Devices 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

EUDAMED SRN
CN-MF-000018408
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (3)

  • EUDAMED 06395b12-31f8-4d9d-adbe-59ed1a53ed57 61 fields · synced Jun 18, 2026
  • FDA UDI 03f4dc30-ae33-48fb-9dc0-3d9a139f2fa6 37 fields · synced May 30, 2026
  • EUDAMED 18c99c6e-5440-486c-b5b1-5e4ec2237d6b 61 fields · synced Jun 18, 2026