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

OPFix with metal ring — Class I MDR by MSP Medizintechnik GmbH

MD Atlas
MSP Medizintechnik GmbH

EUDAMED last updated this device on Aug 8, 2022

OPFix with metal ring

912004788HSOOPFIX87

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MSP Medizintechnik GmbH
UDI-DI code: 09120047880357
Reference / catalog number: HSOOPFIX1000

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: MSP Medizintechnik GmbH
SRN: AT-MF-000018341
Manufacturer status: Inactive

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Austria; available across 1 country total.

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

Device identification

Trade name: OPFix with metal ring
UDI-DI code: 09120047880357
Basic UDI-DI: 912004788HSOOPFIX87
Reference / catalog number: HSOOPFIX1000
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: OPFix ist eine weich gepolsterte, zweiteilige Hand- und Fußfixierung für Patienten jeder Altersgruppe.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0804PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)

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

HSOETT2010912004788HSOETTETOn the market HSOETT2000912004788HSOETTETOn the market HSO08912004788HSOFERSENFIXBUOn the market MamaSafe 20 pairs912004788HSOMASANEOn the market MamaSafe 4 pairs912004788HSOMASANEOn 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.