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Sterile Hypodermic Syringes for Single Use
EUDAMEDClass I (EU MDR)
Ref HS2Z10Model Sterile Hypodermic Syringes for Single Use W/O NEEDLE
Identity
- Trade Name
- Sterile Hypodermic Syringes for Single Use EUDAMED
- Device Name
- Sterile Hypodermic Syringes for Single Use EUDAMED
- Model / Reference
- Sterile Hypodermic Syringes for Single Use W/O NEEDLE EUDAMEDHS2Z10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970969862121 EUDAMED
- Basic UDI-DI
- 697096986063P EUDAMED
- EMDN Code
- A020102010102 INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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 Syringes for Single Use by Zhejiang Longde Pharmaceutical Co., Ltd. — Class I — 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 | 697096986063P | Class I | 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 (1)
- EUDAMED 880ea32f-d1c7-4e07-b32e-5983e416f23e 61 fields · synced Jun 18, 2026