8298

Organization name

HTL-Strefa S.A.

SRN

PL-MF-000002198

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW001

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 3 countries total.

Trade name

not provided

UDI-DI code

05903999600815

Basic UDI-DI

590799609820MU

Reference / catalog number

8298

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

DropSafe Safety Pen Needles are sterile, single-use safety pen needles intended for use with pen injector devices for the injection of drugs.

Additional information URL

https://htl-strefa.com/products/safety-pen-needles/dropsafe/

Clinical sizes

• 5 MU50
• 0.25 MU50

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

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

• A0101010201HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS