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Spectra Optia™ Exchange Set

Spectra Optia Exchange Set

Class IIaMDR 2017/745Not intended for EU marketNo EU repCMR substanceSingle useSterile

Manufacturer: Terumo BCT, Ltd.
Manufacturer SRN: XI-MF-000004232
UDI-DI: 05054638102266
Basic UDI-DI: 5054638OptiaExchMF
Reference: 10226
EMDN: B030199
EMDN description: APHERESIS COLLECTION DEVICES - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 08:07

Manufacturer products View details

Accessory Waste Bag

Class IMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Terumo BCT, Inc.
Manufacturer SRN: US-MF-000001069
UDI-DI: 05020583700406
Basic UDI-DI: 5020583OptiaWastE2
Reference: 70040
EMDN: B030199
EMDN description: APHERESIS COLLECTION DEVICES - OTHER
First on market country: Belgium
Authorised representative: Terumo BCT Europe N.V.
Last updated: 31.07.2026 07:53

Manufacturer products Authorised representative products Authorised representative actors View details

Rika Plasma Bottle

Class IIaMDR 2017/745Not intended for EU marketAnimal tissuesSingle useSterile

Manufacturer: Terumo BCT, Inc.
Manufacturer SRN: US-MF-000001069
UDI-DI: 05020583213005
Basic UDI-DI: 5020583RikaBotPL
Reference: 21300
EMDN: B030199
EMDN description: APHERESIS COLLECTION DEVICES - OTHER
First on market country: -
Authorised representative: Terumo BCT Europe N.V.
Last updated: 31.07.2026 07:53

Manufacturer products Authorised representative products Authorised representative actors View details

Rika Plasma Separation Set

Class IIaMDR 2017/745Not intended for EU marketAnimal tissuesSingle useSterile

Manufacturer: Terumo BCT, Inc.
Manufacturer SRN: US-MF-000001069
UDI-DI: 05020583212008
Basic UDI-DI: 5020583RikaSetRB
Reference: 21200
EMDN: B030199
EMDN description: APHERESIS COLLECTION DEVICES - OTHER
First on market country: -
Authorised representative: Terumo BCT Europe N.V.
Last updated: 31.07.2026 07:53

Manufacturer products Authorised representative products Authorised representative actors View details

Spectra Optia™ SPD-C Connection Set

Spectra Optia SPD-C Connection Set

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Terumo BCT, Inc.
Manufacturer SRN: US-MF-000001069
UDI-DI: 05020583122000
Basic UDI-DI: 5020583OptiaSPDCSetNC
Reference: 12200
EMDN: B030199
EMDN description: APHERESIS COLLECTION DEVICES - OTHER
First on market country: Belgium
Authorised representative: Terumo BCT Europe N.V.
Last updated: 31.07.2026 07:53

Manufacturer products Authorised representative products Authorised representative actors View details

Spectra Optia™ Anticoagulant Adaptor

Anticoagulant Connection Adaptor

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Terumo BCT, Inc.
Manufacturer SRN: US-MF-000001069
UDI-DI: 05020583112216
Basic UDI-DI: 5020583ACAdapterPG
Reference: 11221
EMDN: B030199
EMDN description: APHERESIS COLLECTION DEVICES - OTHER
First on market country: Belgium
Authorised representative: Terumo BCT Europe N.V.
Last updated: 31.07.2026 07:53

Manufacturer products Authorised representative products Authorised representative actors View details

Spectra Optia™ Single Needle Connector

Spectra Optia Single Needle Adaptor

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Terumo BCT, Inc.
Manufacturer SRN: US-MF-000001069
UDI-DI: 05020583112209
Basic UDI-DI: 5020583OptiaSNConnectorH5
Reference: 11220
EMDN: B030199
EMDN description: APHERESIS COLLECTION DEVICES - OTHER
First on market country: Belgium
Authorised representative: Terumo BCT Europe N.V.
Last updated: 31.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

Spectra Optia™ Exchange Set

Spectra Optia Exchange Sets

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Terumo BCT, Inc.
Manufacturer SRN: US-MF-000001069
UDI-DI: 05020583102200
Basic UDI-DI: 5020583OptiaExchBF
Reference: 10220
EMDN: B030199
EMDN description: APHERESIS COLLECTION DEVICES - OTHER
First on market country: Belgium
Authorised representative: Terumo BCT Europe N.V.
Last updated: 31.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

LIPOSORBER

LIPOSORBER LA-15

Class IIbMDR 2017/745On the marketSingle useSterile

Manufacturer: KANEKA Corporation
Manufacturer SRN: JP-MF-000022143
UDI-DI: 04993478010021
Basic UDI-DI: 4993478KNK00642
Reference: LA-15
EMDN: B030201
EMDN description: PLASMAPHERESIS DEVICES AND KITS,
First on market country: Germany
Authorised representative: Kaneka Medical Europe N.V.
Last updated: 31.07.2026 07:44

Manufacturer products Authorised representative products Authorised representative actors View details

Rheofilter ER

Plasma Component Separator

Class IIbMDR 2017/745On the marketSingle useSterile

Manufacturer: SB-KAWASUMI LABORATORIES, INC.
Manufacturer SRN: JP-MF-000011253
UDI-DI: 04987488102173
Basic UDI-DI: 4987488PCS_ER_RB
Reference: ER-4000
EMDN: B030201
EMDN description: PLASMAPHERESIS DEVICES AND KITS,
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

Cascadeflo EC

Plasma Component Separator

Class IIbMDR 2017/745On the marketSingle useSterile

Manufacturer: SB-KAWASUMI LABORATORIES, INC.
Manufacturer SRN: JP-MF-000011253
UDI-DI: 04987488102135
Basic UDI-DI: 4987488PCS_EC_PW
Reference: EC-20W
EMDN: B030201
EMDN description: PLASMAPHERESIS DEVICES AND KITS,
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

04547319000230

Tubing Set for Blood Purification

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: FORTE GROW MEDICAL CO., LTD.
Manufacturer SRN: JP-MF-000013444
UDI-DI: 04547319000230
Basic UDI-DI: 4547319FGM001_TSBPTQ
Reference: CRRT-FSL
EMDN: B0380
EMDN description: APHERESIS DEVICES - ACCESSORIES
First on market country: France
Authorised representative: Asahi Kasei Medical Europe GmbH
Last updated: 31.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmacure

Plasmacure PE

Class IIbMDR 2017/745On the marketSingle useSterile

Manufacturer: Asahi Kasei Medical Co., Ltd.
Manufacturer SRN: JP-MF-000013951
UDI-DI: 04537693900677
Basic UDI-DI: 4537693PL-PE/0012X
Reference: PS-02
EMDN: B030201
EMDN description: PLASMAPHERESIS DEVICES AND KITS,
First on market country: Germany
Authorised representative: Asahi Kasei Medical Europe GmbH
Last updated: 31.07.2026 05:50

Manufacturer products Authorised representative products Authorised representative actors View details

Rheofilter

Rheofilter XR

Class IIbMDR 2017/745On the marketSingle useSterile

Manufacturer: Asahi Kasei Medical Co., Ltd.
Manufacturer SRN: JP-MF-000013951
UDI-DI: 04537693007116
Basic UDI-DI: 4537693RF-XR/0018J
Reference: XR-4000
EMDN: B030203
EMDN description: SINGLE PLASMA COMPONENTS REMOVAL DEVICES AND KITS
First on market country: Germany
Authorised representative: Asahi Kasei Medical Europe GmbH
Last updated: 31.07.2026 05:50

Manufacturer products Authorised representative products Authorised representative actors View details

Cascadeflo

Cascadeflo XC

Class IIbMDR 2017/745On the marketSingle useSterile

Manufacturer: Asahi Kasei Medical Co., Ltd.
Manufacturer SRN: JP-MF-000013951
UDI-DI: 04537693007079
Basic UDI-DI: 4537693CF-XC/001QH
Reference: XC-20
EMDN: B030203
EMDN description: SINGLE PLASMA COMPONENTS REMOVAL DEVICES AND KITS
First on market country: Germany
Authorised representative: Asahi Kasei Medical Europe GmbH
Last updated: 31.07.2026 05:50

Manufacturer products Authorised representative products Authorised representative actors View details

PLASORBA

PLASORBA BR-350(L)

Class IIbMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Asahi Kasei Medical Co., Ltd.
Manufacturer SRN: JP-MF-000013951
UDI-DI: 04537693001992
Basic UDI-DI: 4537693PL-BR/001ZM
Reference: PLASORBA BR-350(L)
EMDN: B030203
EMDN description: SINGLE PLASMA COMPONENTS REMOVAL DEVICES AND KITS
First on market country: Germany
Authorised representative: Asahi Kasei Medical Europe GmbH
Last updated: 31.07.2026 05:50

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUSORBA

IMMUSORBA TR-350(L)

Class IIbMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Asahi Kasei Medical Co., Ltd.
Manufacturer SRN: JP-MF-000013951
UDI-DI: 04537693001947
Basic UDI-DI: 4537693IM-TR/0014L
Reference: IMMUSORBA TR-350(L)
EMDN: B030203
EMDN description: SINGLE PLASMA COMPONENTS REMOVAL DEVICES AND KITS
First on market country: Germany
Authorised representative: Asahi Kasei Medical Europe GmbH
Last updated: 31.07.2026 05:50

Manufacturer products Authorised representative products Authorised representative actors View details

Plasmaflo

Plasmaflo OP

Class IIbMDR 2017/745On the marketSingle useSterile

Manufacturer: Asahi Kasei Medical Co., Ltd.
Manufacturer SRN: JP-MF-000013951
UDI-DI: 04537693001848
Basic UDI-DI: 4537693PL-OP/0016B
Reference: OP-02W(L)
EMDN: B030201
EMDN description: PLASMAPHERESIS DEVICES AND KITS,
First on market country: Germany
Authorised representative: Asahi Kasei Medical Europe GmbH
Last updated: 31.07.2026 05:50

Manufacturer products Authorised representative products Authorised representative actors View details

04262401270024

Whole Blood Sampling Procedure Pack

Class IMDR 2017/745On the market

Manufacturer: DasLab GmbH
Manufacturer SRN: DE-PR-000025410
UDI-DI: 04262401270024
Basic UDI-DI: 426240127PP-BLO-WHPS
Reference: 4262401270024
EMDN: B010199
EMDN description: BLOOD COLLECTION BAGS AND KITS - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 05:31

Manufacturer products View details

04262401270017

Serum Sampling Procedure Pack

Class IMDR 2017/745On the market

Manufacturer: DasLab GmbH
Manufacturer SRN: DE-PR-000025410
UDI-DI: 04262401270017
Basic UDI-DI: 426240127PP-BLO-SEP8
Reference: 4262401270017
EMDN: B010199
EMDN description: BLOOD COLLECTION BAGS AND KITS - OTHER
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 05:31

Manufacturer products View details