8162

Organization name

HTL-Strefa S.A.

SRN

PL-MF-000002198

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  Keep out of reach of children without adult supervision. Avoid infections: Before making an injection, clean and disinfect the injection site. Always follow your facility sharps injury prevention guidelines or local regulations. Do not use if the seal or needle is damaged or missing or if the shield or outer cap needle appears to be damaged. Refer to the instructions for use of the drug and pen injector device for specific storage and handling instructions.

Primary placement in France; available across 5 countries total.

Trade name

not provided

UDI-DI code

D-05907996091584XT

Basic UDI-DI

B-05907996091584XT

Reference / catalog number

8162

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Version 31G x 6 mm 100 pcs

Additional information URL

https://htl-strefa.com/produkty/bezpieczne-igly-do-wstrzykiwaczy/dropsafe/

Clinical sizes

• Penetration depth — 6 MU50
• 0.25 MU50

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

D-05907996091584XT

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• A0101010201HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS