EUDAMED last updated this device on May 8, 2026

Disposable A.V. Fistula Needle Sets(Dull needle series)

6948082702142A3

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 →: 06948082751042
Reference / catalog number: BAIN-A.V.F-050DE

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(Dull 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 Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Disposable A.V. Fistula Needle Sets(Dull 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 →: 06948082751042
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 →: 6948082702142A3
Reference / catalog number: BAIN-A.V.F-050DE
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)06948082751042

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.

Consult instructions for use
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 Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	—	Still on market

Disposable A.V. Fistula Needle Sets(Dull needle series)

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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

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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

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Manufacturer information

Certificates covering this device

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