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latex foley catheter

EUDAMED

Class IIa (EU MDR)

Ref GTFL230_16 Ref GTFL215_16 Ref GTFL230_18

by Ningbo Pinmed Instruments Co., Ltd.

Identity

Trade Name
latex foley catheter EUDAMED
Device Name
latex foley catheter EUDAMED
Model / Reference
GTFL230_16 EUDAMED
GTFL215_16 EUDAMED
GTFL230_18 EUDAMED

Identifiers

Primary DI / UDI-DI
06970879339270 EUDAMED
06970879339072 EUDAMED
06970879339287 EUDAMED
Basic UDI-DI
B-06970879339270 EUDAMED
B-06970879339072 EUDAMED
B-06970879339287 EUDAMED
EMDN Code
U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Lithuania EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

Yes

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

latex foley catheter by Ningbo Pinmed Instruments Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Ningbo Pinmed Instruments Co., Ltd.
EUDAMED SRN
CN-MF-000008488
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (3)

  • EUDAMED 14a0d8d5-4e50-4dfd-bb37-2c858580934a 61 fields · synced Jul 30, 2026
  • EUDAMED 13e1187a-72b5-45c7-a7e0-42ae29b8f93d 61 fields · synced May 18, 2026
  • EUDAMED 29ce46ef-962d-4879-bb37-b1335f35e2ab 61 fields · synced May 18, 2026