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Organization name
UDI-DI code
Reference / catalog number

Transafix Fixing Tape No.1 BULK — Class I MDR

MD Atlas
Transatlantic HG Stolpe & Co. mbH

EUDAMED last updated this device on Aug 24, 2023

Transafix Fixing Tape No.1 BULK

4050856TFRN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Transatlantic HG Stolpe & Co. mbH
UDI-DI code: 04050856024565
Reference / catalog number: 8800101

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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: Transafix Fixing Tape No.1 BULK
UDI-DI code: 04050856024565
Basic UDI-DI: 4050856TFRN
Reference / catalog number: 8800101
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: The Fixation Tape is used as non-invasive medical device to fix medical aids such as probes, catheters, tubes and drains to the patient's body.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

H900299TAPES, MEDICAL/SURGICAL - OTHER

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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