| EMDDB code |
23983
|
| Basic UDI-DI |
590799609810046R
|
| Seadme klass |
Meditsiiniseade
|
| Medical Device Nomenclature |
|
| Risk class |
IIa
|
| Appliance |
-
|
| Device name (in Estonian) |
Pen-nõelad tüüp 810 Clickfine
|
| Device name (in English) |
Pen Needles type 810 Clickfine
|
| Intended use (is Estonian) |
Steriilsed ühekordselt kasutatavad süstevahendi nõelad
Ette nähtud ravimite subkutaanseks süstimiseks pen-süstli abil.
Tervishoiutöötajatele ja tavakasutajatele.
|
| Intended use (in English) |
Sterile, single-use pen needles
Intended for use with pen injector devices for the subcutaneous injection of drugs.
For healthcare professionals and lay users.
|
| Type/model/article number |
pen needle type 810 Clickfine
|
| Additional information |
dimension of pen needles:
0.23 mm x 4 mm (32G x 5/32”)
0.25 mm x 5 mm (31G x 3/16”)
0.25 mm x 6 mm (31G x 1/4")
0.25 mm x 8 mm (31G x 5/16”)
0.33 mm x 5 mm (29G x 3/16”)
0.33 mm x 10 mm (29G x 3/8”)
0.33 mm x 12 mm (29G x 1/2")
|
| Notified body |
0197
|
| Manufacturer |
HTL-STREFA S.A.
|
| In register from |
04/30/2026
|
| Entry status |
Active
|
| Device comments, keywords |
MDR
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
