8013

Organization name

HTL-Strefa S.A.

SRN

PL-MF-000002198

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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.
• CW001

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 4 countries total.

Trade name

not provided

UDI-DI code

05907996093465

Basic UDI-DI

590799609810MR

Reference / catalog number

8013

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

100

Additional product description

droplet pen needles are sterile, single-use needles intended for use with pen injector device for the subcutaneous injection of drugs.

Additional information URL

https://htl-strefa.com/products/pen-needles/droplet-eu-for-patient/

Clinical sizes

• 0.25 MU50
• 6 MU50

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

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

• A0101010202HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS