EUDAMED last updated this device on Jun 2, 2026

FLS2000

697169353012M8

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Super Health Medical (Qingdao) Co.,Ltd.
UDI-DI code: 06971693534643
Reference / catalog number: FLS2000

FLS2000 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Super Health Medical (Qingdao) Co.,Ltd.. Placed on the EU market in Northern Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on Jun 2, 2026

FLS2000

697169353012M8

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Super Health Medical (Qingdao) Co.,Ltd.
UDI-DI code: 06971693534643
Reference / catalog number: FLS2000

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 06971693534643
Basic UDI-DI: 697169353012M8
Reference / catalog number: FLS2000
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06971693534643

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

A03020101LOW PRESSURE EXTENSION LINES

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in XI; available across 32 countries total.

Country	On market since	Until
XIPrimary placement	Sep 12, 2025	Sep 11, 2030
Austria	Sep 12, 2025	Sep 11, 2030
Belgium	Sep 12, 2025	Sep 11, 2030
Bulgaria	Sep 12, 2025	Sep 11, 2030
Cyprus	Sep 12, 2025	Sep 11, 2030
Czechia	Sep 12, 2025	Sep 11, 2030
Germany	Sep 12, 2025	Sep 11, 2030
Denmark	Sep 12, 2025	Sep 11, 2030
Estonia	Sep 12, 2025	Sep 11, 2030
EL	Sep 12, 2025	Sep 11, 2030
Spain	Sep 12, 2025	Sep 11, 2030
Finland	Sep 12, 2025	Sep 11, 2030
France	Sep 12, 2025	Sep 11, 2030
Croatia	Sep 12, 2025	Sep 11, 2030
Hungary	Sep 12, 2025	Sep 11, 2030
Ireland	Sep 12, 2025	Sep 11, 2030
Iceland	Sep 12, 2025	Sep 11, 2030
Italy	Sep 12, 2025	Sep 11, 2030
Liechtenstein	Sep 12, 2025	Sep 11, 2030
Lithuania	Sep 12, 2025	Sep 11, 2030
Luxembourg	Sep 12, 2025	Sep 11, 2030
Latvia	Sep 12, 2025	Sep 11, 2030
Malta	Sep 12, 2025	Sep 11, 2030
Netherlands	Sep 12, 2025	Sep 11, 2030
Norway	Sep 12, 2025	Sep 11, 2030
Poland	Sep 12, 2025	Sep 11, 2030
Portugal	Sep 12, 2025	Sep 11, 2030
Romania	Sep 12, 2025	Sep 11, 2030
Sweden	Sep 12, 2025	Sep 11, 2030
Slovenia	Sep 12, 2025	Sep 11, 2030
Slovakia	Sep 12, 2025	Sep 11, 2030
Türkiye	Sep 12, 2025	Sep 11, 2030

Device identification

Trade name: not provided
UDI-DI code: 06971693534643
Basic UDI-DI: 697169353012M8
Reference / catalog number: FLS2000
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Super Health Medical (Qingdao) Co.,Ltd.
SRN: CN-MF-000023694
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06971693534643

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

A03020101LOW PRESSURE EXTENSION LINES

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

HZ 2187352-1Issued
Quality management systemNotified body: 0197Expiry: Sep 11, 2030

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

All products by Super Health Medical (Qingdao) Co.,Ltd.

Market distribution

Primary placement in XI; available across 32 countries total.

Country	On market since	Until
XIPrimary placement	Sep 12, 2025	Sep 11, 2030
Austria	Sep 12, 2025	Sep 11, 2030
Belgium	Sep 12, 2025	Sep 11, 2030
Bulgaria	Sep 12, 2025	Sep 11, 2030
Cyprus	Sep 12, 2025	Sep 11, 2030
Czechia	Sep 12, 2025	Sep 11, 2030
Germany	Sep 12, 2025	Sep 11, 2030
Denmark	Sep 12, 2025	Sep 11, 2030
Estonia	Sep 12, 2025	Sep 11, 2030
EL	Sep 12, 2025	Sep 11, 2030
Spain	Sep 12, 2025	Sep 11, 2030
Finland	Sep 12, 2025	Sep 11, 2030
France	Sep 12, 2025	Sep 11, 2030
Croatia	Sep 12, 2025	Sep 11, 2030
Hungary	Sep 12, 2025	Sep 11, 2030
Ireland	Sep 12, 2025	Sep 11, 2030
Iceland	Sep 12, 2025	Sep 11, 2030
Italy	Sep 12, 2025	Sep 11, 2030
Liechtenstein	Sep 12, 2025	Sep 11, 2030
Lithuania	Sep 12, 2025	Sep 11, 2030
Luxembourg	Sep 12, 2025	Sep 11, 2030
Latvia	Sep 12, 2025	Sep 11, 2030
Malta	Sep 12, 2025	Sep 11, 2030
Netherlands	Sep 12, 2025	Sep 11, 2030
Norway	Sep 12, 2025	Sep 11, 2030
Poland	Sep 12, 2025	Sep 11, 2030
Portugal	Sep 12, 2025	Sep 11, 2030
Romania	Sep 12, 2025	Sep 11, 2030
Sweden	Sep 12, 2025	Sep 11, 2030
Slovenia	Sep 12, 2025	Sep 11, 2030
Slovakia	Sep 12, 2025	Sep 11, 2030
Türkiye	Sep 12, 2025	Sep 11, 2030

FLS2000

FLS2000

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices