Identity
- Trade Name
- Irrigation Syringe EUDAMEDMicsafe FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- Irrigation Syringe EUDAMED60ml irrigation syringe FDA UDI
- Model / Reference
- Type B 60ml EUDAMEDIV60RT EUDAMED1 FDA UDI
- Description
- 60ml irrigation syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971911294809 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971911294809 EUDAMED
- FDA Product Code
- MEG FDA UDIFMI FDA UDIFMF FDA UDI
- EMDN Code
- A02010299 INFUSION AND IRRIGATION SYRINGES - OTHER EUDAMED
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI880.5570 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose syringe, single-use
Micsafe by Jiangsu Micsafe Medical Tehcnology Co., LTD. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose syringe, single-use.
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- SURGYCO — Surgyco LLC · Class I
- NAMIC — MEDLINE INDUSTRIES, INC. · Class II
- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
- SURGYCO — Surgyco LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Micsafe Medical Tehcnology Co., LTD.
Sources (2)
- FDA UDI 713052c8-ee45-491f-89ad-878b4b3699ed 33 fields · synced Oct 9, 2026
- EUDAMED 0322ca94-8e63-4920-99bf-9b095f23dcc0 61 fields · synced Jun 19, 2026