Identity
- Trade Name
- AgaMatrix Lancing Device EUDAMEDFDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Device Name
- Lancing Device Agamatrix EUDAMED
- Model / Reference
- 830010622 EUDAMED8300-10622 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D-830010622KV EUDAMED00385541062206 FDA UDI
- Basic UDI-DI
- B-830010622KV EUDAMED
- 510(k) Number
- K230310 FDA UDI
- FDA Product Code
- QRL FDA UDIQRK FDA UDI
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
- GMDN Term
- Manual blood lancing device, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual blood lancing device, reusable
AgaMatrix Lancing Device by Agamatrix, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual blood lancing device, reusable.
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- Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II
Cleared under the same submission
K230310 also covers:
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
- Agamatrix, Inc.
Sources (2)
- FDA UDI a4a6e712-0fad-4b88-9c11-f75a25c1647a 34 fields · synced Jul 25, 2026
- EUDAMED bd882627-48b8-4ebe-9a1b-fdaeae8cc298 61 fields · synced Jul 25, 2026