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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

47002 — Class I MDR by Rosa Toifl & Co GmbH

MD Atlas
Rosa Toifl & Co GmbH

EUDAMED last updated this device on Feb 22, 2023

47002

9010845OP-Mantel-QK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Rosa Toifl & Co GmbH
UDI-DI code: 09010845001019
Reference / catalog number: 47002

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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: 09010845001019
Basic UDI-DI: 9010845OP-Mantel-QK
Reference / catalog number: 47002
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+BW Mantel "L"
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T020401STANDARD SURGICAL GOWNS

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 433509010845OP-Raum-A2On 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.