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Organization name
UDI-DI code
Reference / catalog number

GW480-035 — Class IIa MDD by EPflex Feinwerktechnik…

MD Atlas
EPflex Feinwerktechnik GmbH

EUDAMED last updated this device on Oct 14, 2022

GW480-035

B-GW480-035NJ

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: EPflex Feinwerktechnik GmbH
UDI-DI code: D-GW480-035NJ
Reference / catalog number: GW480-035

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Manufacturer information

Organization name: EPflex Feinwerktechnik GmbH
SRN: DE-MF-000005425
Manufacturer status: Active

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-GW480-035NJ
Basic UDI-DI: B-GW480-035NJ
Reference / catalog number: GW480-035
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

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

EMDN nomenclature code(s)

C0499CARDIOVASCULAR GUIDEWIRES - OTHER

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

1000266008Issued
Technical documentationNotified body: 0297Expiry: Jul 2, 2029
1000265993Issued
Quality management systemNotified body: 0297Expiry: Nov 8, 2028