Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

44011651 — Class III MDD by EPflex Feinwerktechnik…

MD Atlas
EPflex Feinwerktechnik GmbH

EUDAMED last updated this device on Oct 11, 2022

44011651

B-440116517X

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: EPflex Feinwerktechnik GmbH
UDI-DI code: D-440116517X
Reference / catalog number: 44011651

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Denmark		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-440116517X
Basic UDI-DI: B-440116517X
Reference / catalog number: 44011651
Issuing entity: EUDAMED

Classification

Risk category: Class III
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

Related devices

Appollo42556056gwcIIaFPOn the market Appollo42556056gwcIIaFPOn the market Appollo42556056gwcIIaFPOn the market Dashwire42556056gwcIIaFPOn the market Dashwire42556056gwcIIaFPOn the market

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.