Identity
- Trade Name
- Disposable Irrigation Syringe EUDAMEDChuangjia FDA UDI
- Generic Name
- Irrigation syringe FDA UDI
- Device Name
- Disposable Irrigation Syringe EUDAMED
- Model / Reference
- 60ml EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06957933263030 EUDAMED06957933218405 FDA UDI
- Basic UDI-DI
- 69579332cj0196M EUDAMED
- FDA Product Code
- KYZ FDA UDI
- EMDN Code
- A02010203 INFUSION AND IRRIGATION SYRINGES, CATHETER CONE, SINGLE-USE EUDAMED
- GMDN Term
- Irrigation syringe FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6960 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Irrigation syringe
Chuangjia by Changzhou Chuangjia Medical Appliance Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Irrigation syringe.
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- Monoject — Cardinalhealth · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Changzhou Chuangjia Medical Appliance Co., Ltd.
Sources (2)
- FDA UDI b9063c7b-efe0-4020-82a0-3b44f415000d 32 fields · synced Jul 20, 2026
- EUDAMED 4db4d585-1ad7-49e8-a299-9c17260fb5f7 61 fields · synced Jul 20, 2026