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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

D100100 — Class I MDR by Transatlantic HG Stolpe…

MD Atlas
Transatlantic HG Stolpe & Co. mbH

EUDAMED last updated this device on Aug 23, 2023

D100100

4050856NDQY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Transatlantic HG Stolpe & Co. mbH
UDI-DI code: 04050856043313
Reference / catalog number: D100100

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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.

Critical warnings

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

CW999
Die Nase darf nicht gespült werden: bei starken Nasenbluten, wenn eine Nasenhöhle verstopft ist oder eine Beeinträchtigung der Ohren oder des inneren Gehörgangs vorliegt, wenn durch Verletzungen am Nasendach und an den Nasenhöhlen wänden direkte Verbindungen zu den Flüssigkeitsräumen des Gehirns bestehen.

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: not provided
UDI-DI code: 04050856043313
Basic UDI-DI: 4050856NDQY
Reference / catalog number: D100100
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 nasal douche consists of a blue-transparent plastic bottle with a push button at the bottom (air inlet valve), through which the air inlet for the rinsing process is enabled. On the bottle there is the rinsing neck with a rinsing nozzle.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0899MEDICAL SUPPORT EQUIPMENT - 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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