Identity
- Trade Name
- EXEL 1mL Allergy Syringes 27G x 1/2", Regular Bevel EUDAMEDExel Allergy Syringes FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- EXEL Allergy Syringes EUDAMEDAllergy Syringes, 1cc, 27G X 1/2, regular bevel FDA UDI
- Model / Reference
- 26061 EUDAMEDFDA UDI
- Description
- Allergy Syringes, 1cc, 27G X 1/2, regular bevel FDA UDI
Identifiers
- Catalog Number
- 26061 FDA UDI
- Primary DI / UDI-DI
- 10020221260615 EUDAMEDFDA UDI
- Basic UDI-DI
- 20221SYRALG260KS EUDAMED
- Unit of Use DI
- 00020221260618 EUDAMED
- 510(k) Number
- K861153 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A02010204 INFUSION AND IRRIGATION SYRINGES, WITHOUT CONE, WITH FIXED NEEDLE, SINGLE-USE EUDAMED
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Austria 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
Yes
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
Exel Allergy Syringes by Exel International — Class II — MDR, 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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- NAMIC — MEDLINE INDUSTRIES, INC. · Class II
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- BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
- SURGYCO — Surgyco LLC · Class I
Cleared under the same submission
K861153 also covers:
- 50-60mL SYR ONLY L-L BULK NON STERILE — Exel International
- EXEL 0.3mL INS SYR 28GX1/2" — Exel International
- EXEL 0.3mL INS SYR 30GX1/2" — Exel International
- EXEL 10-12mL SYR L-L BULK NON STRILE; — Exel International
- EXEL 1mL ALLERGY SYR 27GX1/2", REGULAR BEVEL — Exel International
- EXEL 1mL SYR ONLY LUER LOCK BULK NON-STERILE — Exel International
- EXEL 1mL SYR ONLY LUER LOCK BULK NON-STERILE **CUSTOM** — Exel International
- EXEL 1ml SYR ONLY LUER LOCK BULK, STERILE — Exel International
- EXEL 20-25mL SYR ONLY L-L BULK NON STERILE, NO PRINT ON BARREL — Exel International
- EXEL 20-25mL SYR ONLY L-L BULK NON STERILE; — Exel International
- EXEL 20-25mL SYR ONLY L-S/N-S — Exel International
- EXEL 30-35mL SYR ONLY L-S /N-S — Exel International
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exel International
Sources (2)
- FDA UDI 19848fed-fdb4-4d20-9f8c-da623392ca44 35 fields · synced Jun 18, 2026
- EUDAMED b2bc77e1-56e3-4072-9958-f5482af64920 61 fields · synced Jun 18, 2026