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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

48012544 — Class IIa MDD by EPflex Feinwerktechnik…

MD Atlas
EPflex Feinwerktechnik GmbH

EUDAMED last updated this device on Nov 2, 2022

48012544

B-48012544A8

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: EPflex Feinwerktechnik GmbH
UDI-DI code: D-48012544A8
Reference / catalog number: 48012544

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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-48012544A8
Basic UDI-DI: B-48012544A8
Reference / catalog number: 48012544
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)

U0602UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC

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

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.