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Organization name
UDI-DI code
Reference / catalog number

1628 — Class IIa MDR by Med SSE System GmbH

MD Atlas
Med SSE System GmbH

EUDAMED last updated this device on Apr 8, 2026

1628

PP19221AT107

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Med SSE System GmbH
UDI-DI code: 111691478888
Reference / catalog number: 1628

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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 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 1983	Still on market
Netherlands		Still on market

Device identification

Trade name: not provided
UDI-DI code: 111691478888
Basic UDI-DI: PP19221AT107
Reference / catalog number: 1628
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 cone-shaped design is ideal for all incontinence indications. It closes the straight intestine like a ball valve, seals off the anal canal through the bulge in the middle, and ideally adapts to the anatomy due to the tapering.
Additional information URL: https://www.medsse.de/de/pva/tabelle_kegel.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

Related devices

7401PP19221ZB485On the market 7400PP19221ZB485On the market 1636PP19221AT107On the market 1160PP19221AT107On the market applicator bigPP19221ZB485On the market

Certificates

Certificate health across this manufacturer's portfolio.

DZ 1620448-1Amended
Quality assuranceNotified body: 0197Expiry: Sep 15, 2030