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Organization name
UDI-DI code
Reference / catalog number

LENTELL Fistula Touch XL — Class I MDR by Lentismed d.o.o.

MD Atlas
Lentismed d.o.o.

EUDAMED last updated this device on Feb 1, 2023

LENTELL Fistula Touch XL

385889221stomaprodsSF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lentismed d.o.o.
UDI-DI code: 03858892216637
Reference / catalog number: 201151

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Manufacturer information

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

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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: LENTELL Fistula Touch XL
UDI-DI code: 03858892216637
Basic UDI-DI: 385889221stomaprodsSF
Reference / catalog number: 201151
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: 1
Additional product description: One-piece drainable wound bag transparent, max. cut 50/140 mm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A100199DEVICES FOR ABDOMINAL OSTOMY - ONE PIECE - OTHER

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