Identity
- Trade Name
- controlfine EUDAMED
- Device Name
- Insulin Pen Needles EUDAMED
- Model / Reference
- IPN-32-4 EUDAMEDIPN31*5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965290282 EUDAMED06975965290275 EUDAMED
- Basic UDI-DI
- 697122740IPNPZ EUDAMED
- Unit of Use DI
- 86975965290288 EUDAMED86975965290271 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
controlfine by Promisemed Hangzhou Meditech Co., Ltd. — 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 | 697122740IPNPZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008465
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED a9409be6-e5e8-40cb-b155-b3878c2710f6 61 fields · synced Oct 7, 2026
- EUDAMED 4a095eee-a178-409d-b8ce-977f92fb7b2c 61 fields · synced May 17, 2026