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

Stack / Staxx splint — Class I MDR by Dr. Paul Koch GmbH

MD Atlas
Dr. Paul Koch GmbH

EUDAMED last updated this device on Jun 29, 2022

Stack / Staxx splint

426043325kustolag59

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr. Paul Koch GmbH
UDI-DI code: 04260433255972
Reference / catalog number: 3000100

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: Dr. Paul Koch GmbH
SRN: DE-MF-000006364
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: Stack / Staxx splint
UDI-DI code: 04260433255972
Basic UDI-DI: 426043325kustolag59
Reference / catalog number: 3000100
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.dr-koch.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060603FINGERS ORTHOSES

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

10320000;64426043325metlagschieUQOn the market 10320000;73426043325metlagschieUQOn the market 10320000;92426043325metlagschieUQOn the market 10322000;88426043325metlagschieUQOn the market 10322000;89426043325metlagschieUQOn 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.