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Organization name
UDI-DI code
Reference / catalog number

101501 — Class I MDR by Lentismed d.o.o.

MD Atlas
Lentismed d.o.o.

EUDAMED last updated this device on Jan 13, 2023

101501

385889221cathetershydroJE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lentismed d.o.o.
UDI-DI code: 03858892211212
Reference / catalog number: 101501

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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

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

CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
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: 03858892211212
Basic UDI-DI: 385889221cathetershydroJE
Reference / catalog number: 101501
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: 30
Additional product description: Hydrophilic Urinary Catheter, LentisCath+ Nelaton, Male, 10 Fr/Ch, 40cm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U01010501NELATON CATHETERS, SELF-LUBRICATING

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