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Organization name
UDI-DI code
Reference / catalog number

400826 — Class IIb MDR by Pharmazeutische Fabrik…

MD Atlas
Pharmazeutische Fabrik Montavit Ges.m.b.H.

EUDAMED last updated this device on Apr 28, 2026

400826

9001505CATHEJELL004HF

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pharmazeutische Fabrik Montavit Ges.m.b.H.
UDI-DI code: 09001505008264
Reference / catalog number: 400826

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Manufacturer information

Organization name: Pharmazeutische Fabrik Montavit Ges.m.b.H.
SRN: AT-MF-000001620
Manufacturer status: Active

Critical warnings

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

CW135
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
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: 09001505008264
Basic UDI-DI: 9001505CATHEJELL004HF
Reference / catalog number: 400826
Issuing entity: GS1

Classification

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

Device details

Quantity: 25
Additional product description: sterile, water-soluble, visually clear lubricant gel for the insertion of catheters, endoscopes, probes, or other medical instruments to protect the mucosa and to reduce pain and discomfort for the patient / for procedures in the urogenital tract via intraurethral, intravaginal and suprapubic pathways, as well as in the respiratory and upper/ lower gastrointestinal tract via oro- and nasopharyngeal and endorectal pathways
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9007STERILE INSTRUMENT LUBRICANTS

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

400151B-09001505001517On the market 4008249001505CATHEJELL004HFOn the market 4008259001505CATHEJELL004HFOn the market

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.