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Natural rubber latex male condom

small size (49±2mm) , medium size (53mm±2mm), large size (55mm±2mm), extra-large size (58mm±2mm); Smooth, Studs, Ribs

Class IIbMDR 2017/745On the marketContains latexDirect markingSingle use

Manufacturer: Suzhou Colour-way New Material Co., Ltd.
Manufacturer SRN: CN-MF-000027396
UDI-DI: 06925634024113
Basic UDI-DI: 69256340MLC3H
Reference: 53mm±2mm
EMDN: U110101
EMDN description: CONDOMS
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 31.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Nelaton Catheter

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Hangzhou Formed Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000011212
UDI-DI: 06923310901086
Basic UDI-DI: 69233109PU03PY
Reference: PU030208
EMDN: U01010502
EMDN description: NELATON CATHETERS, NON SELF-LUBRICATING
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:18

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Foley Catheter for single use latex Two-way with ballone 2.0mm(6Fr)

Model：Two-way with ballonet, Three-way with ballonet； Specifications：2.0mm(6Fr), 2.7mm(8Fr), 3.3mm(10Fr), 4.0mm(12Fr), 4.7mm(14Fr), 5.3mm(16Fr),6.0mm(18Fr),6.7mm(20Fr),7.3mm(22Fr),8.0mm(24Fr), 8.7mm(26Fr), 9.3mm(28Fr), 10.0mm(30Fr).

Class IIaMDR 2017/745On the marketContains latexSingle useSterile

Manufacturer: Jiangxi Hongda Medical Equipment Group Ltd.
Manufacturer SRN: CN-MF-000006019
UDI-DI: 06920756758335
Basic UDI-DI: 69207567DNG0001GL
Reference: FR06D
EMDN: U020202
EMDN description: URETERAL CATHETERS WITH FLUTE TIP WITH BALLOON
First on market country: Hungary
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

YA emätingeeli 7x5ml

BV-gel (Bacterial vaginosis vaginal gel)

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Galena Pharma Oy
Manufacturer SRN: FI-MF-000000588
UDI-DI: 06420615710752
Basic UDI-DI: 642061571350169BQ
Reference: 422005
EMDN: U0803
EMDN description: VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

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YA Liukugeeli 100ml

Lubricant

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Galena Pharma Oy
Manufacturer SRN: FI-MF-000000588
UDI-DI: 06420615710745
Basic UDI-DI: 642061571350221AZ
Reference: 425115
EMDN: U0803
EMDN description: VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

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Femisan Cream emätinvoide + aplikaattori 50g

VAGINAL CREAM + APPLICATOR

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Galena Pharma Oy
Manufacturer SRN: FI-MF-000000588
UDI-DI: 06420615710691
Basic UDI-DI: 642061571725125CS
Reference: 725125
EMDN: U0803
EMDN description: VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

Manufacturer products View details

Femisan Cream emätinvoide 25g

VAGINAL CREAM

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Galena Pharma Oy
Manufacturer SRN: FI-MF-000000588
UDI-DI: 06420615710677
Basic UDI-DI: 642061571350193BM
Reference: 350193/725156
EMDN: U0803
EMDN description: VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:37

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ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 6 FG / 2-WAY

ULTRAMED SILICONE FOLEY BALLOON CATHETER

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)
Manufacturer SRN: EG-MF-000038562
UDI-DI: 06223004251320
Basic UDI-DI: 622300425SFC3007SP
Reference: 3007-6/2
EMDN: U010299
EMDN description: URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 17:30

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ULTRAMED SILICONE COATED LATEX FOLEY BALLOON CATHETER Size 6 FG / 2-WAY

ULTRAMED SILICONE COATED LATEX FOLEY BALLOON CATHETER

Class IIaMDR 2017/745On the marketContains latexSingle useSterile

Manufacturer: Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)
Manufacturer SRN: EG-MF-000038562
UDI-DI: 06223004251184
Basic UDI-DI: 622300425LFC3006NW
Reference: 3006-6/2
EMDN: U010201
EMDN description: URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 17:30

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ULTRAMED NELATON CATHETER Size 6 FG

ULTRAMED NELATON CATHETER

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E)
Manufacturer SRN: EG-MF-000038562
UDI-DI: 06223004250019
Basic UDI-DI: 622300425NEC3001P9
Reference: 3001-6
EMDN: U01010502
EMDN description: NELATON CATHETERS, NON SELF-LUBRICATING
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 17:30

Manufacturer products Authorised representative products Authorised representative actors View details

Ellavi UBT

UBT

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: SINAPI Biomedical (Pty) Ltd
Manufacturer SRN: ZA-MF-000012126
UDI-DI: 06009888639016
Basic UDI-DI: 60099003902UBTUL
Reference: UBT-Deluxe
EMDN: U100102
EMDN description: POSTPARTUM INTRAUTERINE CATHETERS
First on market country: Spain
Authorised representative: mdi Europa GmbH
Last updated: 31.07.2026 16:48

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Hollister

Male Incontinence Sheath (Catheter)

Class IMDR 2017/745On the marketSingle use

Manufacturer: Hollister Incorporated
Manufacturer SRN: US-MF-000027818
UDI-DI: 00610075973255
Basic UDI-DI: 610075D01P030S00606H
Reference: 97325
EMDN: U070201
EMDN description: SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE
First on market country: Ireland
Authorised representative: Hollister ULC
Last updated: 31.07.2026 16:44

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GM felnőtt nadrágpelenka S (1200 ml)

VIZELETFELSZÍVÓ ÉS DEFEKÁLÁSI SEGÉDESZKÖZÖK

Class IMDR 2017/745On the marketReprocessedSingle use

Manufacturer: PATELLA-96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000004588
UDI-DI: 05999542973642
Basic UDI-DI: 599954297GM0930QF
Reference: GM felnőtt nadrágpelenka S (1200 ml)
EMDN: U070299
EMDN description: EXTERNAL DEVICES FOR THE TREATMENT OF INCONTINENCE - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:38

Manufacturer products View details

GM betegalátét 40x60 cm

BETEGALÁTÉTEK

Class IMDR 2017/745On the market

Manufacturer: PATELLA-96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000004588
UDI-DI: 05999542971624
Basic UDI-DI: 599954297GM0940QJ
Reference: GM egyszerhasználatos antidecubitus alátét 40x60 cm
EMDN: U070201
EMDN description: SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:37

Manufacturer products View details

IALUADAPTER/UroDapter

IALUADATER/UroDapter

Class IMDR 2017/745On the marketAdministering medicineSingle useSterile

Manufacturer: Pharmico Medical Korlátolt felelősségi társaság - MF
Manufacturer SRN: HU-MF-000018352
UDI-DI: 05996617000050
Basic UDI-DI: 5996617ADAPTER7F
Reference: www.urosystem.hu
EMDN: U0199
EMDN description: URETHRAL PROSTATIC AND BLADDER CATHETERS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 31.07.2026 16:29

Manufacturer products View details

Halova

Halova ovules

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Perfect Care Manufacturing SRL
Manufacturer SRN: RO-MF-000024062
UDI-DI: 05944757500039
Basic UDI-DI: 5944757502halovaovulepcPE
Reference: DM12
EMDN: U0803
EMDN description: VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:17

Manufacturer products View details

Cerviron

DM01

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Perfect Care Manufacturing SRL
Manufacturer SRN: RO-MF-000024062
UDI-DI: 05944757500015
Basic UDI-DI: 59447575ovulevaginale01ST
Reference: DM01
EMDN: U0803
EMDN description: VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:17

Manufacturer products View details

APLIKATOR DOPOCHWOWY 100

APLIKATORY DOPOCHWOWE

Class IMDR 2017/745On the marketAdministering medicine

Manufacturer: Lubelskie Zakłady Farmaceutyczne "POLFA" Spółka Akcyjna
Manufacturer SRN: PL-MF-000015608
UDI-DI: 05906188005491
Basic UDI-DI: 5906188Aplikatory-kI3U
Reference: QAPL-0001-000
EMDN: U0899
EMDN description: GYNAECOLOGICAL DEVICES - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:12

Manufacturer products View details

Sealing Connector (T-Piece)

SUR019

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Calyx Medical Sp. z o.o.
Manufacturer SRN: PL-MF-000038787
UDI-DI: 05906168942259
Basic UDI-DI: 59061689422SUR019M2
Reference: SUR019
EMDN: U090199
EMDN description: URINARY STONE RETRIEVAL DEVICES - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:12

Manufacturer products View details

Sealing Connector (S-Piece)

SUR021

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Calyx Medical Sp. z o.o.
Manufacturer SRN: PL-MF-000038787
UDI-DI: 05906168942242
Basic UDI-DI: 59061689422SUR021LM
Reference: SUR021
EMDN: U090199
EMDN description: URINARY STONE RETRIEVAL DEVICES - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:12

Manufacturer products View details