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PVC Resuscitator

1690-0003

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931348
Basic UDI-DI: B-04710961931348
Reference: 1690-0003
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

Manufacturer products Authorised representative products Authorised representative actors View details

PVC Resuscitator

1690-0002

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931331
Basic UDI-DI: B-04710961931331
Reference: 1690-0002
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

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PVC Resuscitator

1690-0001

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931324
Basic UDI-DI: B-04710961931324
Reference: 1690-0001
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

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Silicone Resuscitator

1610-0003

Class IIaMDDOn the marketSingle use

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04710961931287
Basic UDI-DI: B-04710961931287
Reference: 1610-0003
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 11:02

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JF1197 JFA Resuscitation Shield 483-1#

Resuscitation Shield

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Suzhou Sunmed Co.,Ltd.
Manufacturer SRN: CN-MF-000010170
UDI-DI: 06973864851634
Basic UDI-DI: 697386485JFACPRVB
Reference: JF1197
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Ireland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:34

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16970531332837

HXN

Class IIaMDR 2017/745Not intended for EU marketContains latexDirect markingSingle use

Manufacturer: Shaoxing Undis Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000002187
UDI-DI: 16970531332837
Basic UDI-DI: 697053133bblVD
Reference: 2L
EMDN: R03020101
EMDN description: ANAESTHESIA BALLOONS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 21:23

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POLYMED

BY-QN-00，BY-QN-01，BY-QN-02，BY-QN-03，BY-QN-10，BY-QN-11，BY-QN-12，BY-QN-13

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Ningbo Boya Medical Equipment Co., Ltd
Manufacturer SRN: CN-MF-000032282
UDI-DI: 06951467493093
Basic UDI-DI: 69514674150001XB
Reference: BY-QN-01
EMDN: R03020101
EMDN description: ANAESTHESIA BALLOONS
First on market country: Czechia
Authorised representative: Caretechion GmbH
Last updated: 31.07.2026 20:21

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T-piece Infant Resuscitation System

BQ70

Class IIbMDR 2017/745On the marketActive deviceAdministering medicineDirect marking

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429020991
Basic UDI-DI: 69454290BQ001KC
Reference: BQ70
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Finland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:11

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06938119387771

PVC type(Adult,Child,Infant)

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Henan Tuoren Medical Device Co., Ltd
Manufacturer SRN: CN-MF-000013924
UDI-DI: 06938119387771
Basic UDI-DI: 693811937367KA
Reference: MRPAO00
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: France
Authorised representative: MedNet EC-REP C III GmbH
Last updated: 31.07.2026 19:08

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06924993400118

HONZ-SM-B/HONZ-SM-O/HONZ-M-O/HONZ-M-CL/HONZ-M-CS

Class IMDR 2017/745On the marketSingle use

Manufacturer: Honz Pharmaceutical Co,.Ltd.
Manufacturer SRN: CN-MF-000024508
UDI-DI: 06924993400118
Basic UDI-DI: 692499340735365G
Reference: MDR
EMDN: R030299
EMDN description: RESPIRATORY BALLOONS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 18:25

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PEEP Valve, 5~20 cmH2O, 30F

Disposable PEEP VALVE

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980101502
Basic UDI-DI: 69239801ND2OAPQ
Reference: AV0004
EMDN: R030280
EMDN description: RESPIRATORY BALLONS - ACCESSORIES
First on market country: Poland
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:20

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DispoBag, Child w/Pop-Off, Mask

Disposable Manual Resuscitator

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed (Xiamen) Co., Ltd.
Manufacturer SRN: CN-MF-000020627
UDI-DI: 06923980101083
Basic UDI-DI: 69239801ND2PAPT
Reference: AR0022
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:20

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Manual Resuscitator

Silicone

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Hangzhou Formed Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000011212
UDI-DI: 06923310902533
Basic UDI-DI: 69233109PA40619A
Reference: PA40611111
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:18

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Manual Resuscitator

Class IMDR 2017/745On the marketSingle use

Manufacturer: AUG MEDICAL Spółka z ograniczoną odpowiedzialnością
Manufacturer SRN: PL-MF-000019086
UDI-DI: 05904507279004
Basic UDI-DI: 590450727RD32CN
Reference: AU-60152
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:47

Manufacturer products View details

Manual Resuscitator

Class IMDR 2017/745On the marketReusable

Manufacturer: AUG MEDICAL Spółka z ograniczoną odpowiedzialnością
Manufacturer SRN: PL-MF-000019086
UDI-DI: 05904507279035
Basic UDI-DI: 590450727UB19D9
Reference: AU-60349
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 13:43

Manufacturer products View details

Breathing Bag, 1L, Silicone, w/ Over-MoldCuff

Disposable Reservoir Bag - Silicone

Class IMDR 2017/745No longer on the marketSingle use

Manufacturer: Winnomed Company Ltd.
Manufacturer SRN: TW-MF-000037459
UDI-DI: 04719897760275
Basic UDI-DI: 471989776642NN
Reference: 64201
EMDN: R03020199
EMDN description: VENTILATION BALLOONS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Breathing Bag, 1L, Latex-Free

Disposable Reservoir Bag - Latex/Latex-Free

Class IMDR 2017/745No longer on the marketSingle use

Manufacturer: Winnomed Company Ltd.
Manufacturer SRN: TW-MF-000037459
UDI-DI: 04719897760015
Basic UDI-DI: 471989776641NL
Reference: 64101
EMDN: R03020199
EMDN description: VENTILATION BALLOONS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Manometer, 0~60cmH2O

(L) Resuscitator

Class IIaMDR 2017/745On the marketMeasuring functionSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810114380
Basic UDI-DI: 471081008NNLP9Q
Reference: AP0006
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:26

Manufacturer products Authorised representative products Authorised representative actors View details

Diverter Cap w/Valve, 30F

(L) Resuscitator

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810113574
Basic UDI-DI: 471081008NNLVA4
Reference: AV0049
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:26

Manufacturer products Authorised representative products Authorised representative actors View details

MR-100 Silicone Reservoir Bag, 1L

(L) Resuscitator

Class IIaMDR 2017/745On the market

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
UDI-DI: 04710810083464
Basic UDI-DI: 471081008RNL38U
Reference: AR0098
EMDN: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:25

Manufacturer products Authorised representative products Authorised representative actors View details