Organization name

Bioteque Corporation

SRN

TW-MF-000015568

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• Caution

  1. The application of the direct access method is recommended for those cavities only which are not covered by any organs or intestines. 2.It is not possible to exclude the possibility that the lumen of the lumen of the catheter will clog, and therefore perfect drainage can no longer be guaranteed. In such case, you should replace drainage catheter.

• Consult instructions for use
• Do not re-use
• Do not resterilize
• Do not use if package is damaged

Primary placement in Denmark; available across 32 countries total.

Trade name

BIOTEQ

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

04712052081505

Basic UDI-DI

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.

B-04712052081505

Reference / catalog number

BT-PD1-1240-W/ D11012035

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 40 MU10
• 12 MU170

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• A060299PERCUTANEOUS DRAINAGE SYSTEMS - OTHER

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.