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Glucoject
EUDAMEDClass IIa (EU MDR)
Ref 4090Model Type 810Ref 4081Ref 4080Ref 4084Ref 4109Ref 4085Ref 4089Ref 4082Ref 4106Ref 4110Ref 4087Ref 4107
Identity
- Trade Name
- Glucoject EUDAMED
- Device Name
- Pen needle EUDAMED
- Model / Reference
- Type 810 EUDAMED4090 EUDAMED4081 EUDAMED4080 EUDAMED4084 EUDAMED4109 EUDAMED4085 EUDAMED4089 EUDAMED4082 EUDAMED4106 EUDAMED4110 EUDAMED4087 EUDAMED4107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903999606428 EUDAMED05903999606336 EUDAMED05903999606329 EUDAMED05903999606367 EUDAMED05903999607838 EUDAMED05903999606374 EUDAMED05903999606411 EUDAMED05903999606343 EUDAMED05903999607807 EUDAMED05903999607845 EUDAMED05903999606398 EUDAMED05903999607814 EUDAMED
- Basic UDI-DI
- 590799609810EFH EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Glucoject by Htl Strefa S A — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 590799609810EFH | Class IIa | Active |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (12)
- EUDAMED 22ac182c-b860-4d09-bef9-1d4fcd0a7d7c 61 fields · synced Aug 4, 2026
- EUDAMED 9251e603-2367-4719-b1d8-9a62e21e3bea 61 fields · synced May 16, 2026
- EUDAMED 5d33e0dd-adac-458c-acfb-cd50e4cf040a 61 fields · synced May 16, 2026
- EUDAMED dcf3f185-b270-4c4d-937a-33137aa0eaec 61 fields · synced May 17, 2026
- EUDAMED 8fe8df43-427a-43df-aa89-d647f0942c53 61 fields · synced May 17, 2026
- EUDAMED 4d205a87-439b-4cf0-8763-cb58484fb366 61 fields · synced May 17, 2026
- EUDAMED ee2f8b97-7699-4504-b3a8-a1fd263851b0 61 fields · synced May 17, 2026
- EUDAMED 3ac2d406-bb7c-4484-94b1-496caca89679 61 fields · synced May 18, 2026
- EUDAMED d7e0d4aa-2049-4ce2-a3ea-d6e0c01d57b2 61 fields · synced May 18, 2026
- EUDAMED b85d28eb-95d9-4a01-a87b-edb183fca143 61 fields · synced May 18, 2026
- EUDAMED 0674d672-8014-46d1-88ce-0746af80cc36 61 fields · synced May 18, 2026
- EUDAMED e4d265ef-98e6-4901-92fc-a79c512a85ef 61 fields · synced May 18, 2026