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LENTELL ColoTouch XL +1 more model

EUDAMED

Class I (EU MDR)

Ref 201142-1Ref 201148-1Ref 201142Ref 201148

by Lentismed d.o.o.

Identity

Trade Name
LENTELL ColoTouch XL; transparent EUDAMED
LENTELL ColoTouch XL EUDAMED
Device Name
Ostomy Products EUDAMED
Model / Reference
201142-1 EUDAMED
201148-1 EUDAMED
201142 EUDAMED
201148 EUDAMED

Identifiers

Primary DI / UDI-DI
03858892217351 EUDAMED
03858892217368 EUDAMED
03858892216132 EUDAMED
03858892216156 EUDAMED
Basic UDI-DI
385889221stomaprodsSF EUDAMED
EMDN Code
A1001010101 ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, W/O TISSUE COVER EUDAMED
A1001010102 ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER EUDAMED
Models / Variants
LENTELL ColoTouch XL EUDAMED
transparent EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Croatia EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

LENTELL ColoTouch XL +1 more model by Lentismed d.o.o. — Class I — MDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Lentismed d.o.o.
EUDAMED SRN
HR-MF-000018298

Sources (4)

  • EUDAMED 3150dcbf-7a5e-4277-bfae-31317d362bbf 61 fields · synced Jul 26, 2026
  • EUDAMED 8b6efa86-b9c0-4273-a01d-9738f5477ddd 61 fields · synced May 17, 2026
  • EUDAMED cb7603d9-e871-4e24-83be-aa431c5ddb7b 61 fields · synced May 18, 2026
  • EUDAMED 1ed7911a-5525-4e66-9c30-5ff136b24b2b 61 fields · synced May 19, 2026