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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

4150 — Class IIa MDR by Med SSE System GmbH

MD Atlas
Med SSE System GmbH

EUDAMED last updated this device on Nov 9, 2022

4150

PP19221PT367

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Med SSE System GmbH
UDI-DI code: 111691583633
Reference / catalog number: 4150

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Manufacturer information

Organization name: Med SSE System GmbH
SRN: DE-MF-000008104
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 111691583633
Basic UDI-DI: PP19221PT367
Reference / catalog number: 4150
Issuing entity: IFA

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The proctologist's tampon with a continuous inner hole tion provides benefits in postoperative use of the doctor and for the benefit of the patient decisive product advantages: • Bleeding above the packed anal canal are noticed more quickly since the blood will leak out can • Blood accumulation is prevented, thus not uncomfortable due to possible post-bleeding pressure on the patient • post-operative gases easily removed via the drainage
Additional information URL: https://www.medsse.de/de/proktologie/produktinformationen.php
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U070199INTERNAL SYSTEMS FOR THE TREATMENT OF INCONTINENCE - 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.