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EXEL 1mL CARRYING AND DELIVERY SYRINGE;
EUDAMEDFDA UDIClass I (EU MDR)
Ref OSTDS1
Identity
- Trade Name
- EXEL 1mL CARRYING AND DELIVERY SYRINGE; EUDAMEDEXEL 1mL Delivery Syringes EUDAMEDEXEL 1mL CARRYING AND DELIVERY SYRINGE FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- Syringe Only EUDAMEDEXEL 1mL Delivery Syringe EUDAMEDEXEL 1mL CARRYING AND DELIVERY SYRINGE; 10PCS/PK, 10PK/BX, 1000PC/CASE FDA UDI
- Model / Reference
- OSTDS1 EUDAMEDFDA UDI
- Description
- EXEL 1mL CARRYING AND DELIVERY SYRINGE; 10PCS/PK, 10PK/BX, 1000PC/CASE FDA UDI
Identifiers
- Catalog Number
- OSTDS1 FDA UDI
- Primary DI / UDI-DI
- 00020221017809 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221017809 EUDAMED20221DLVRYSYRJ4 EUDAMED
- 510(k) Number
- K861153 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMEDA02010299 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 UDI
- Market of Registration
- Netherlands EUDAMEDAustria 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
EUDAMEDEUDAMED
Measuring Function
No
EUDAMEDEUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
EXEL 1mL CARRYING AND DELIVERY SYRINGE; by Exelint International, Co. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00020221017809 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00020221017809 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 9f55a90d-9173-475a-830b-835d62447d8f 61 fields · synced Jul 26, 2026
- FDA UDI 0e15d395-686c-4103-ab64-358dc041ade3 36 fields · synced May 30, 2026
- EUDAMED f1136183-0a41-4e0b-af10-8c76688fd0a9 61 fields · synced Jul 26, 2026