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

201113A — Class I MDR by Lentismed d.o.o.

MD Atlas
Lentismed d.o.o.

EUDAMED last updated this device on Aug 13, 2024

201113A

385889221stomaprodsSF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lentismed d.o.o.
UDI-DI code: 03858892218907
Reference / catalog number: 201113A

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

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, 19cm385889221cathetersgelPAOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

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.

Placed on the market in Croatia; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 03858892218907
Basic UDI-DI: 385889221stomaprodsSF
Reference / catalog number: 201113A
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: 15
Additional product description: One-piece drainable urostomy bag, max. cut 60 mm, pouch size 15x23 cm, Opaque with Inspection Window
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A1001030102ONE-PIECE UROSTOMY 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