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Organization name
UDI-DI code
Reference / catalog number

32400350-25-15 — Class IIa MDR by Robert Helwig GmbH

MD Atlas
Robert Helwig GmbH

EUDAMED last updated this device on Apr 10, 2026

32400350-25-15

42516106Injektion9A

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Robert Helwig GmbH
UDI-DI code: 04251610691171
Reference / catalog number: 32400350-25-15

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Manufacturer information

Organization name: Robert Helwig GmbH
SRN: DE-MF-000012987
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
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	May 23, 2025	Still on market
Austria	May 23, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04251610691171
Basic UDI-DI: 42516106Injektion9A
Reference / catalog number: 32400350-25-15
Issuing entity: GS1

Classification

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

Device details

Quantity: 20
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 4,00 x 350 mm

EMDN nomenclature code(s)

A01010199HYPODERMIC NEEDLES - 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.