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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

Vaginal Applicator for Soft-capsule — Class I MDR

MD Atlas
Manfred Schägner GmbH

EUDAMED last updated this device on Nov 11, 2021

Vaginal Applicator for Soft-capsule

404331105vag_applB2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Manfred Schägner GmbH
UDI-DI code: 04043311000082
Reference / catalog number: 102201

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Manufacturer information

Organization name: Manfred Schägner GmbH
SRN: DE-MF-000006001
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.

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		Still on market
XI		Still on market

Device identification

Trade name: Vaginal Applicator for Soft-capsule
UDI-DI code: 04043311000082
Basic UDI-DI: 404331105vag_applB2
Reference / catalog number: 102201
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: drug delivery device for introducing a drug (soft capsule) into the vagina
Additional information URL: https://www.schaegner.de/wp-content/uploads/2021/04/vaginal-soft-capsule-applicator-IFU-202102-de.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - 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
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Software identification