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Iberian care
EUDAMEDClass IIa (EU MDR)
Ref MIS-053008-100 Model Type 7,Type 7-u100,Type 7-u40,
Identity
- Trade Name
- Iberian care EUDAMED
- Device Name
- Safety Insulin Syringe;Safety Syringe with Fixed Needle EUDAMED
- Model / Reference
- Type 7,Type 7-u100,Type 7-u40, EUDAMEDMIS-053008-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965292675 EUDAMED
- Basic UDI-DI
- 697122740MISQA EUDAMED
- Unit of Use DI
- 86975965292671 EUDAMED
- EMDN Code
- A02010601 INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Iberian care 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 | 697122740MISQA | 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 (1)
- EUDAMED a8a196f4-ac6b-4015-baef-64e1b140cb81 61 fields · synced Jun 19, 2026