EUDAMED last updated this device on May 7, 2026

Disposable A.V.Fistula Needle Sets(Safety Needle series)

6948082702152A6

On the marketClass IIa

Applicable legislation: —
Organization name: Bain Medical Equipment(Guangzhou)Co.,Ltd.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06948082770074
Reference / catalog number: BAIN-A.V.F-034SE

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

Disposable A.V.Fistula Needle Sets(Safety Needle series) is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Bain Medical Equipment(Guangzhou)Co.,Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Disposable A.V.Fistula Needle Sets(Safety Needle series)
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06948082770074
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 6948082702152A6
Reference / catalog number: BAIN-A.V.F-034SE
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIa
Applicable legislation: —
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)06948082770074

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.

A010401ARTERIOVENOUS FISTULA NEEDLES

Critical warnings

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

CW999
Special contraindications are unknown. Contraindications for dialysis are applicable. Strict monitoring shall be performed for the patients who have tendencies of blood bleeding or clotting during the treatment. Treatment shall be terminated in the event of any complications affecting patient's condition.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 8 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Bulgaria	—	Still on market
EL	—	Still on market
Hungary	—	Still on market
Lithuania	—	Still on market
Netherlands	—	Still on market
Poland	—	Still on market
Romania	—	Still on market

Related searches

Class IIa medical devices in EUDAMED

Device identification

Trade name: Disposable A.V.Fistula Needle Sets(Safety Needle series)
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06948082770074
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 6948082702152A6
Reference / catalog number: BAIN-A.V.F-034SE
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Critical warnings

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

CW999
Special contraindications are unknown. Contraindications for dialysis are applicable. Strict monitoring shall be performed for the patients who have tendencies of blood bleeding or clotting during the treatment. Treatment shall be terminated in the event of any complications affecting patient's condition.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 8 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Bulgaria	—	Still on market
EL	—	Still on market
Hungary	—	Still on market
Lithuania	—	Still on market
Netherlands	—	Still on market
Poland	—	Still on market
Romania	—	Still on market

Disposable A.V.Fistula Needle Sets(Safety Needle series)

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

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

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates covering this device

Related devices

Certificates