Identity
- Trade Name
- Sterile Syringes for Single Use EUDAMED
- Device Name
- Sterile Syringes for Single Use W/O NEEDLE EUDAMED
- Model / Reference
- PC2Z01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970969865849 EUDAMED
- Basic UDI-DI
- 697096986083T EUDAMED
- EMDN Code
- A020102010202 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile 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 | 697096986083T | 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 5b2ea568-7b92-49a7-9da0-b54a79ad5f13 61 fields · synced Jun 18, 2026