Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

32150015 — Class IIa MDR by Robert Helwig GmbH

MD Atlas
Robert Helwig GmbH

EUDAMED last updated this device on Mar 24, 2026

32150015

42516106Injektion9A

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Robert Helwig GmbH
UDI-DI code: 04251610632389
Reference / catalog number: 32150015

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

7750014042516106SaugkanuelenVGOn the market 3205010042516106Injektion9AOn the market 3205011042516106Injektion9AOn the market 3205012042516106Injektion9AOn the market 3205014042516106Injektion9AOn 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.

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: 04251610632389
Basic UDI-DI: 42516106Injektion9A
Reference / catalog number: 32150015
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: 25
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 1,50 x 15 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