Identity
- Trade Name
- Sterile Syringes for Single Use EUDAMED
- Device Name
- Sterile Syringes for Single Use W/O NEEDLE EUDAMED
- Model / Reference
- PC1Z01 EUDAMEDPC2S01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970969865825 EUDAMED06970969865832 EUDAMED
- Basic UDI-DI
- 697096986083T EUDAMED
- EMDN Code
- A020102010202 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMEDA020102020102 INFUSION AND IRRIGATION SYRINGES, LUER LOCK 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhejiang Longde Pharmaceutical Co., Ltd.
- EUDAMED SRN
- CN-MF-000021623
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED d493e68f-20f6-4d34-ad55-2080baf68037 61 fields · synced Jul 30, 2026
- EUDAMED fd7be728-1c80-470c-a4ea-6a6d4e4f2d60 61 fields · synced May 19, 2026