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

01365 — Class IIa MDR by RAPID Biomedical GmbH

MD Atlas
RAPID Biomedical GmbH

EUDAMED last updated this device on Sep 7, 2023

01365

426048768FAMSurf_IIaKM

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: RAPID Biomedical GmbH
UDI-DI code: 04260487680959
Reference / catalog number: 01365

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: RAPID Biomedical GmbH
SRN: DE-MF-000008285
Manufacturer status: Active

Related devices

02254426048768FAMTorso_IIaALOn the market 02226426048768FAMTorso_IIaALOn the market 02227426048768FAMTorso_IJROn the market 02214426048768FAMSurf_IIaKMOn the market 02296426048768FAMSurf_IIaKMOn the market

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW014
EUDAMED did not publish a description for this code.

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: 04260487680959
Basic UDI-DI: 426048768FAMSurf_IIaKM
Reference / catalog number: 01365
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11059080VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES

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

Certificate health across this manufacturer's portfolio.

HZ 1419035-1refdata.certificate-status.reissued
Quality management systemNotified body: 0197Expiry: Feb 11, 2031
HZ 1419035-1Issued
Quality management systemNotified body: 0197Expiry: Feb 11, 2026