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Organization name
UDI-DI code
Reference / catalog number

Transaroll Hygieneboard Standard — Class I MDR

MD Atlas
Transatlantic HG Stolpe & Co. mbH

EUDAMED last updated this device on Aug 30, 2023

Transaroll Hygieneboard Standard

4050856TRSE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Transatlantic HG Stolpe & Co. mbH
UDI-DI code: 04050856035493
Reference / catalog number: 4500026

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Manufacturer information

Organization name: Transatlantic HG Stolpe & Co. mbH
SRN: DE-MF-000009432
Manufacturer status: Active

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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.

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: Transaroll Hygieneboard Standard
UDI-DI code: 04050856035493
Basic UDI-DI: 4050856TRSE
Reference / catalog number: 4500026
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: app. 180 x 50 cm, foldable. The hygienic board is made of the basic body, which is foldable or non-foldable, depending on the variant. A roll of disposable gliding cover is provided with the basic body. The basic body and disposable gliding cover result in the product hygienic board. It is mainly used for special hygienic requirements.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V080504PATIENT TRANSFER BOARDS AND TABLES

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

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