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AccuTip Covers, 600/bx, bulk
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref AX11286510(k) K132549
Identity
- Trade Name
- AccuTip Covers, 600/bx, bulk EUDAMEDAccuTip Cover FDA UDI
- Generic Name
- Ophthalmic tonometer tip cover FDA UDI
- Device Name
- AccuTip Covers, 600/bx, bulk EUDAMEDBulk, non-sleeved FDA UDI
- Model / Reference
- AX11286 EUDAMEDFDA UDI
- Description
- Bulk, non-sleeved FDA UDI
Identifiers
- Catalog Number
- AX11286 FDA UDI
- Primary DI / UDI-DI
- 00897826002116 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00897826002116 EUDAMED
- FDA Product Code
- HKY FDA UDI
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Ophthalmic tonometer tip cover FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
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
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
Yes
FDA UDI
AccuTip Covers, 600/bx, bulk by Accutome Inc. DBA Keeler USA — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132549 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00897826002116 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Accutome Inc. DBA Keeler USA
- EUDAMED SRN
- US-MF-000036181
- FDA Applicant
- Accutome, Inc.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 2c1e39f3-20eb-40d1-ac89-b4b43e6cd9fc 85 fields · synced Jun 18, 2026
- FDA UDI 6969b222-1807-4f7c-864a-bdaae28ea3ed 34 fields · synced May 30, 2026
- FDA 510(k) K132549 1 fields · synced May 18, 2026