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Disposable A.V. Fistula Needle Sets

AVF-BR2515BE-15, AVF-BR2515BE-16, AVF-BR2515E-15, AVF-BR2515E-16

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Bain Medical Equipment(Guangzhou)Co.,Ltd.
Manufacturer SRN: CN-MF-000005196
UDI-DI: 06948082771323
Basic UDI-DI: 69480827021329Y
Reference: AVF-BR2515E-16
EMDN: A010401
EMDN description: ARTERIOVENOUS FISTULA NEEDLES
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 20:13

Manufacturer products Authorised representative products Authorised representative actors View details

DORA Apheresis Needle

7R2460, 7R2461, 7R2462

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Bain Medical Equipment(Guangzhou)Co.,Ltd.
Manufacturer SRN: CN-MF-000005196
UDI-DI: 06948082772962
Basic UDI-DI: 6948082722082AY
Reference: 7R2460
EMDN: A010199
EMDN description: NEEDLES FOR INFUSION AND COLLECTION - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 20:13

Manufacturer products Authorised representative products Authorised representative actors View details

DORA Fistula Catheter

BAIN-FC-001, BAIN-FC-001S, BAIN-FC-002, BAIN-FC-002S, BAIN-FC-003, BAIN-FC-003S, BAIN-FC-004, BAIN-FC-004S, BAIN-FC-005, BAIN-FC-005S, BAIN-FC-006, BAIN-FC-006S

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Bain Medical Equipment(Guangzhou)Co.,Ltd.
Manufacturer SRN: CN-MF-000005196
UDI-DI: 06948082751936
Basic UDI-DI: 6948082720282AU
Reference: BAIN-FC-001
EMDN: A010401
EMDN description: ARTERIOVENOUS FISTULA NEEDLES
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 20:12

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DORA Disposable A.V. Fistula Needle Sets

BAIN-A.V.F-002, BAIN-A.V.F-006, BAIN-A.V.F-038T, BAIN-A.V.F-042T, BAIN-A.V.F-046T, BAIN-A.V.F-048T

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Bain Medical Equipment(Guangzhou)Co.,Ltd.
Manufacturer SRN: CN-MF-000005196
UDI-DI: 06948082700996
Basic UDI-DI: 69480827021319W
Reference: BAIN-A.V.F-001
EMDN: A010401
EMDN description: ARTERIOVENOUS FISTULA NEEDLES
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 20:12

Manufacturer products Authorised representative products Authorised representative actors View details

Suction Adaptor

Class IMDR 2017/745On the market

Manufacturer: Hangzhou Hawk Optical Electronic Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000028791
UDI-DI: 06947014619900
Basic UDI-DI: 69470146RJ00457210U8
Reference: P1461
EMDN: A0799
EMDN description: ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER
First on market country: Türkiye
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:12

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Multi-Patient Syringe System

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Shenzhen Antmed Co., Ltd
Manufacturer SRN: CN-MF-000029659
UDI-DI: 06945764440324
Basic UDI-DI: 69457644MSS0000011Q9
Reference: R289107
EMDN: A020102010102
EMDN description: INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITHOUT NEEDLE, SINGLE-USE
First on market country: Netherlands
Authorised representative: MedNet EC-REP C IIb GmbH
Last updated: 31.07.2026 20:12

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06945630112737

Lancing Device

Class IMDR 2017/745On the marketReusable

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 06945630112737
Basic UDI-DI: 6945630102BB
Reference: LDE4 02-2201
EMDN: A99
EMDN description: DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 20:12

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Auxiliary Water Tube

CM-AWT1

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429086485
Basic UDI-DI: 69454290WT002TA
Reference: CM-AWT1
EMDN: A0380
EMDN description: TUBULAR DEVICES - ACCESSORIES
First on market country: Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:12

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Water Tube

CM-WT32

Class IIaMDR 2017/745On the market

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429086461
Basic UDI-DI: 69454290WT001T8
Reference: CM-WT32
EMDN: A0380
EMDN description: TUBULAR DEVICES - ACCESSORIES
First on market country: Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:12

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Endoscopic Flushing Pump

FP-6

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429063059
Basic UDI-DI: 69454290FP001LH
Reference: FP-6
EMDN: A03010299
EMDN description: IRRIGATION CONTROLLERS - OTHER
First on market country: Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:11

Manufacturer products Authorised representative products Authorised representative actors View details

06945326860881

BENUA1

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Beijing L&Z Medical Technology Development Co., Ltd.
Manufacturer SRN: CN-MF-000019471
UDI-DI: 06945326860881
Basic UDI-DI: 69453268X0701MX
Reference: BENUA1 1201
EMDN: A080101
EMDN description: ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

06945326860829

BEKX

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Beijing L&Z Medical Technology Development Co., Ltd.
Manufacturer SRN: CN-MF-000019471
UDI-DI: 06945326860829
Basic UDI-DI: 69453268X0104M7
Reference: BEKX 04025A
EMDN: A080102
EMDN description: PARENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

06945326860171

BECPB2/BEEPB2

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Beijing L&Z Medical Technology Development Co., Ltd.
Manufacturer SRN: CN-MF-000019471
UDI-DI: 06945326860171
Basic UDI-DI: 69453268X0304MH
Reference: BECPB2 13211
EMDN: A080101
EMDN description: ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

06945326860010

BECPA2，BEEPA2

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Beijing L&Z Medical Technology Development Co., Ltd.
Manufacturer SRN: CN-MF-000019471
UDI-DI: 06945326860010
Basic UDI-DI: 69453268X0303MF
Reference: BECPA2 13211
EMDN: A080101
EMDN description: ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

06945326838989

BEDX/BEEX/BEHX/BEJX

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Beijing L&Z Medical Technology Development Co., Ltd.
Manufacturer SRN: CN-MF-000019471
UDI-DI: 06945326838989
Basic UDI-DI: 69453268X0103M5
Reference: BEDX 120010
EMDN: A080102
EMDN description: PARENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

06945326835209

BEAE/BEBE/BECE/BEFE

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Beijing L&Z Medical Technology Development Co., Ltd.
Manufacturer SRN: CN-MF-000019471
UDI-DI: 06945326835209
Basic UDI-DI: 69453268X0102M3
Reference: BEAE 010111
EMDN: A080102
EMDN description: PARENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

06945326835087

BEAP/BEBP/BECP/BEFP

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Beijing L&Z Medical Technology Development Co., Ltd.
Manufacturer SRN: CN-MF-000019471
UDI-DI: 06945326835087
Basic UDI-DI: 69453268X0101LZ
Reference: BEAP 010111
EMDN: A080102
EMDN description: PARENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

06945326829482

BECGB1/BEEGB1

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Beijing L&Z Medical Technology Development Co., Ltd.
Manufacturer SRN: CN-MF-000019471
UDI-DI: 06945326829482
Basic UDI-DI: 69453268X0202M8
Reference: BECGB1 12000
EMDN: A080101
EMDN description: ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details

06945326828683

BECGA1/BEEGA1

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Beijing L&Z Medical Technology Development Co., Ltd.
Manufacturer SRN: CN-MF-000019471
UDI-DI: 06945326828683
Basic UDI-DI: 69453268X0201M6
Reference: BECGA1 12000
EMDN: A080101
EMDN description: ENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details

Ostomy bag

Class IMDR 2017/745On the marketSingle use

Manufacturer: WUHAN HUAWEI TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000014668
UDI-DI: 06945296006425
Basic UDI-DI: 69452960OstomyBag001LN
Reference: 1204
EMDN: A1099
EMDN description: ABDOMINAL OSTOMY DEVICES - OTHER
First on market country: Finland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details