Data from EUDAMED, last updated May 24, 2026

Ostomy Products

385889221stomaprodsSF

186 references

Class I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk category: Class I
Manufacturer: Lentismed d.o.o.

Device family identification

Device name: Ostomy Products
Basic UDI-DI: 385889221stomaprodsSF
Issuing agency: GS1
Version date: Dec 22, 2021

Classification

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

Manufacturer

Name: Lentismed d.o.o.
SRN: HR-MF-000018298
Country: Croatia
Email: lentismed@lentismed.com
Phone: +385 1 558 4259

Device characteristics

No device characteristics flagged

References by status

Role
Country
Date of registration
Address

EMDN code(s)

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

A1001010101One-piece colostomy bags for non-retracted stoma, flat, w/o tissue cover
A1001010102One-piece colostomy bags for non-retracted stoma, flat, with tissue cover
A1001010202One-piece colostomy bags for retracted stoma, convex, with tissue cover
A1001020101One-piece ileostomy bags for non-retracted stoma, flat, w/o tissue cover
A1001020102One-piece ileostomy bags for non-retracted stoma, flat, with tissue cover
A1001020202One-piece ileostomy bags for retracted stoma, convex, with tissue cover
A1001030101One-piece urostomy bags for non-retracted stoma, flat, w/o tissue cover
A1001030102One-piece urostomy bags for non-retracted stoma, flat, with tissue cover
A1001030202One-piece urostomy bags for retracted stoma, convex, with tissue cover
A100104Expansion caps for abdominal ostomy systems - one piece
A100199Devices for abdominal ostomy - one piece - other
A1002010401Universal plates for abdominal stoma (colo-, ileo-, urostomy) with non-introflex stoma
A1002010402Universal plates for abdominal stoma (colo-, ileo-, urostomy) with introflex stoma
A10020201Colostomy bags for two-part systems, w/o tissue cover
A10020202Colostomy bags for two-part systems, with tissue cover
A10020301Ileostomy bags for two-part systems, w/o tissue cover
A10020302Ileostomy bags for two-part systems, with tissue cover
A10020401Urostomy bags for two-part systems, w/o tissue cover
A10020402Urostomy bags for two-part systems, with tissue cover
A100205Expansion caps for two-piece abdominal ostomy systems
A1099Abdominal ostomy devices - other

References

186 references

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
201105A	`201105A`	`03858892218785`	20	On the market
201104A	`201104A`	`03858892218761`	20	On the market
201145LET	`201145LET`	`03858892218747`	10	On the market
201102A	`201102A`	`03858892218723`	20	On the market
201101A	`201101A`	`03858892218709`	20	On the market
201111A	`201111A`	`03858892218884`	15	On the market
201110A	`201110A`	`03858892218860`	15	On the market
201146LET	`201146LET`	`03858892218846`	10	On the market
201108A	`201108A`	`03858892218822`	20	On the market
201107A	`201107A`	`03858892218808`	20	On the market
201141A	`201141A`	`03858892218983`	15	On the market
201115A	`201115A`	`03858892218969`	15	On the market
201147LET	`201147LET`	`03858892218945`	10	On the market
201172A	`201172A`	`03858892218921`	15	On the market
201113A	`201113A`	`03858892218907`	15	On the market
201123	`201123`	`03858892214442`	1	On the market
LENTELL basic II kids	`201123AB`	`03858892216736`	1	On the market
201123ET	`201123ET`	`03858892219003`	10	On the market
201118	`201118`	`03858892214336`	1	On the market
201118AB	`201118AB`	`03858892211021`	1	On the market
201118ET	`201118ET`	`03858892219041`	10	On the market
LENTELL Basic II M	`201152AB`	`03858892218044`	10	On the market
LENTELL Basic II M	`201152`	`03858892218068`	10	On the market
201117	`201117`	`03858892214329`	1	On the market
201117AB	`201117AB`	`03858892218020`	1	On the market