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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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsView 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 productsView details
04260531390018

IMPACT Platform for Autologous Cell Therapies

Class IIaMDR 2017/745On the marketActive deviceDirect marking
Manufacturer
Plasmaconcept AG
Manufacturer SRN
DE-MF-000005281
UDI-DI
04260531390018
Basic UDI-DI
426053139IMP210000DX
Reference
210000
EMDN
B0499
EMDN description
AUTOTRANSFUSION DEVICES - OTHER
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 02:09
Manufacturer productsView details
FractioPlas® 10

Plasma Fractionator

Class IIaMDR 2017/745On the marketSingle useSterile
Manufacturer
MTP Medical Technologies GmbH
Manufacturer SRN
DE-MF-000009601
UDI-DI
04260229350928
Basic UDI-DI
426022935FRA-F.XE
Reference
8302
EMDN
B030203
EMDN description
SINGLE PLASMA COMPONENTS REMOVAL DEVICES AND KITS
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 01:44
Manufacturer productsView details
SepaPlas® 06

Plasmafilter

Class IIaMDR 2017/745On the marketSingle useSterile
Manufacturer
MTP Medical Technologies GmbH
Manufacturer SRN
DE-MF-000009601
UDI-DI
04260229350911
Basic UDI-DI
426022935PLA-F.ZE
Reference
8301/ IBP4251
EMDN
B030201
EMDN description
PLASMAPHERESIS DEVICES AND KITS,
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 01:44
Manufacturer productsView details
04250478417985

Venenstauer

Class IMDR 2017/745On the market
Manufacturer
BODY PRODUCTS RELAX Pharma und Kosmetik GmbH
Manufacturer SRN
DE-MF-000005302
UDI-DI
04250478417985
Basic UDI-DI
42504784775P6
Reference
704003-b-10
EMDN
B99
EMDN description
HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 00:38
Manufacturer productsView details
04250478405968

Venenstauer

Class IMDR 2017/745On the market
Manufacturer
BODY PRODUCTS RELAX Pharma und Kosmetik GmbH
Manufacturer SRN
DE-MF-000005302
UDI-DI
04250478405968
Basic UDI-DI
42504784775P6
Reference
704003-b
EMDN
B99
EMDN description
HAEMATOLOGY AND HAEMOTRANSFUSION DEVICES - OTHER
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 00:34
Manufacturer productsView details
RoweTrans ExtensionLine

Transfusionssysteme

Class IIaMDR 2017/745On the marketSingle useSterile
Manufacturer
RoweMed AG - Medical 4 Life
Manufacturer SRN
DE-MF-000005350
UDI-DI
04250347603235
Basic UDI-DI
42503476TRANSFUSIONCE
Reference
A-3002
EMDN
B0180
EMDN description
BLOOD BAGS AND KITS - ACCESSORIES
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 00:05
Manufacturer productsView details