Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

201108CET — Class I MDR by Lentismed d.o.o.

MD Atlas
Lentismed d.o.o.

EUDAMED last updated this device on Apr 3, 2026

201108CET

385889221stomaprodsSF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lentismed d.o.o.
UDI-DI code: 03858892220023
Reference / catalog number: 201108CET

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Lentismed d.o.o.
SRN: HR-MF-000018298
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Croatia; available across 1 country total.

Country	On market since	Until
CroatiaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03858892220023
Basic UDI-DI: 385889221stomaprodsSF
Reference / catalog number: 201108CET
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 20
Additional product description: One-piece drainable ileostomy bag beige with extended wear time, max. cut 70 mm, clamp closure, pouch size 15x29 cm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A1001020102ONE-PIECE ILEOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

M.2022.MDR.1008Issued
Quality assuranceNotified body: 2696Expiry: Dec 11, 2027

Related devices

CompactCath Nelaton, Female, 10 Fr/Ch, 19cm385889221cathetersgelPAOn the market CompactCath Nelaton, Female, 12 Fr/Ch, 19cm385889221cathetersgelPAOn the market CompactCath Nelaton, Female, 14 Fr/Ch, 19cm385889221cathetersgelPAOn the market CompactCath Nelaton, Female, 16 Fr/Ch, 19cm385889221cathetersgelPAOn the market

CompactCath Nelaton, Female, 18 Fr/Ch, 19cm

385889221cathetersgelPA

On the market