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Sterile Hypodermic Insulin Syringes for Single Use
EUDAMEDClass IIa (EU MDR)
Ref IS1713013Model Sterile Hypodermic Insulin Syringes For single Use WITH NEEDLERef IS21L1Model Sterile Hypodermic Insulin Syringes For single Use W/O NEEDLE
Identity
- Trade Name
- Sterile Hypodermic Insulin Syringes for Single Use EUDAMED
- Device Name
- Sterile Hypodermic Insulin Syringes for Single Use EUDAMED
- Model / Reference
- Sterile Hypodermic Insulin Syringes For single Use WITH NEEDLE EUDAMEDIS1713013 EUDAMEDSterile Hypodermic Insulin Syringes For single Use W/O NEEDLE EUDAMEDIS21L1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970969865474 EUDAMED06970969865856 EUDAMED
- Basic UDI-DI
- 697096986023F EUDAMED697096986073R EUDAMED
- EMDN Code
- A02010601 INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE EUDAMEDA02010602 INSULIN SYRINGES W/O FIXED NEEDLES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Hypodermic Insulin Syringes for Single Use by Zhejiang Longde Pharmaceutical Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 697096986023F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Longde Pharmaceutical Co., Ltd.
- EUDAMED SRN
- CN-MF-000021623
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 860aee58-03c4-4de2-8c8e-c2a9690b791f 61 fields · synced Jul 31, 2026
- EUDAMED d638e93c-96a5-4cab-9641-4393e2f83ada 61 fields · synced May 18, 2026