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06974594960047

15ml

IVD Class AIVDR 2017/746On the marketDirect markingSingle useSterile

Manufacturer: HBH BIOTECHNOLOGY LIMITED
Manufacturer SRN: CN-MF-000033712
UDI-DI: 06974594960047
Basic UDI-DI: 69745949615mlRW
Reference: 004
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Romania
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:40

Manufacturer products Authorised representative products Authorised representative actors View details

06974594960030

13ml

IVD Class AIVDR 2017/746On the marketDirect markingSingle useSterile

Manufacturer: HBH BIOTECHNOLOGY LIMITED
Manufacturer SRN: CN-MF-000033712
UDI-DI: 06974594960030
Basic UDI-DI: 69745949613mlRL
Reference: 003
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Romania
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:40

Manufacturer products Authorised representative products Authorised representative actors View details

06974594960023

10ml

IVD Class AIVDR 2017/746On the marketDirect markingSingle useSterile

Manufacturer: HBH BIOTECHNOLOGY LIMITED
Manufacturer SRN: CN-MF-000033712
UDI-DI: 06974594960023
Basic UDI-DI: 69745949610mlR5
Reference: 10ml
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Romania
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:40

Manufacturer products Authorised representative products Authorised representative actors View details

06974594960016

7ml

IVD Class AIVDR 2017/746On the marketDirect markingSingle useSterile

Manufacturer: HBH BIOTECHNOLOGY LIMITED
Manufacturer SRN: CN-MF-000033712
UDI-DI: 06974594960016
Basic UDI-DI: 6974594967ml2Q
Reference: 001
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Romania
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:40

Manufacturer products Authorised representative products Authorised representative actors View details

Lunsafe

Sputum Collection Device

IVD Class AIVDR 2017/746Not intended for EU marketSingle use

Manufacturer: Creative Biosciences (Guangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000034058
UDI-DI: 06974591041121
Basic UDI-DI: 6974591041003AU
Reference: KLM-100301
EMDN: W05019003
EMDN description: SPUTUM COLLECTION DEVICES
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 16:39

Manufacturer products Authorised representative products Authorised representative actors View details

Colosafe

Stool Collection Device

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Creative Biosciences (Guangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000034058
UDI-DI: 06974591041015
Basic UDI-DI: 6974591041001AQ
Reference: KLM-100101
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 16:39

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565363

ST6001

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565363
Basic UDI-DI: 697454156016L8
Reference: ST6001
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541563185

ST7001-3, ST8001-3, ST9001-3

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541563185
Basic UDI-DI: 697454156005L3
Reference: ST7001-3
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:27

Manufacturer products Authorised representative products Authorised representative actors View details

06974541563048

ST7001-0, ST7001-1, ST7001-2, ST8001-0, ST8001-1, ST8001-2, ST9001-0, ST9001-1, ST9001-2

IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541563048
Basic UDI-DI: 697454156004KZ
Reference: ST7001-2
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:27

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Collection Kit

CY-90001T,CY-93050T,CY-93050TS,CY-93050RT,CY-96000T,CY-98000TS,CY-F1-10,CY-90003T-Stuart,CY-90003T-Amies,CY-90003T-Cary Blair,CY-F005-10,CY-93050AM,CY-90002T,CY-95000BM,CY98000T, etc

IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: Huachenyang (Shenzhen) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000020236
UDI-DI: 06974488992161
Basic UDI-DI: 697448899CY-F0/0/5/2/3V7J
Reference: CY-90003T-Stuart
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal/Endocervical Specimen Collection kit

STTY04

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Suzhou Shengtian Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000009632
UDI-DI: 06974478980581
Basic UDI-DI: 697447898STTY04BZ
Reference: STTY04
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal/Endocervical Specimen Collection kit

STTY01

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Suzhou Shengtian Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000009632
UDI-DI: 06974478980550
Basic UDI-DI: 697447898STTY01BT
Reference: STTY01
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal/Endocervical Specimen Collection Tube

STTY0401

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Suzhou Shengtian Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000009632
UDI-DI: 06974478980543
Basic UDI-DI: 697447898STTY04015N
Reference: STTY0401
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal/Endocervical Specimen Collection kit

STTY03

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Suzhou Shengtian Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000009632
UDI-DI: 06974478980574
Basic UDI-DI: 697447898STTY03BX
Reference: STTY03
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal/Endocervical Specimen Collection kit

STTY02

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Suzhou Shengtian Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000009632
UDI-DI: 06974478980567
Basic UDI-DI: 697447898STTY02BV
Reference: STTY02
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal/Endocervical Specimen Collection Tube

STTY0301

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Suzhou Shengtian Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000009632
UDI-DI: 06974478980536
Basic UDI-DI: 697447898STTY03015H
Reference: STTY0301
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal/Endocervical Specimen Collection Tube

STTY0201

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Suzhou Shengtian Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000009632
UDI-DI: 06974478980529
Basic UDI-DI: 697447898STTY02015C
Reference: STTY0201
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal/Endocervical Specimen Collection Tube

STTY0101

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Suzhou Shengtian Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000009632
UDI-DI: 06974478980512
Basic UDI-DI: 697447898STTY010157
Reference: STTY0101
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

Oral Fluid Collection Kit

STGJ04

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Suzhou Shengtian Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000009632
UDI-DI: 06974478980505
Basic UDI-DI: 697447898STGJ046T
Reference: STGJ04
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

Oral Fluid Collection Kit

STGJ03

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Suzhou Shengtian Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000009632
UDI-DI: 06974478980499
Basic UDI-DI: 697447898STGJ036R
Reference: STGJ03
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details