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

43350 — Class I MDR by Rosa Toifl & Co GmbH

MD Atlas
Rosa Toifl & Co GmbH

EUDAMED last updated this device on Feb 23, 2023

43350

9010845OP-Raum-A2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Rosa Toifl & Co GmbH
UDI-DI code: 09010845005017
Reference / catalog number: 43350

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: Rosa Toifl & Co GmbH
SRN: AT-MF-000020516
Manufacturer status: Active

Critical warnings

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

CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW022
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: not provided
UDI-DI code: 09010845005017
Basic UDI-DI: 9010845OP-Raum-A2
Reference / catalog number: 43350
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: MI-Abdeckhaube
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T030102COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS

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

50009010845OP-Set-WWOn the market 231609010845OP-Raum-A2On the market 470029010845OP-Mantel-QKOn the market 470019010845OP-Mantel-QKOn the market 231049010845OP-Tuch-BTOn 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.