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AccuTip Covers, 100 sleeved bulk bag
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AX11526
Identity
- Trade Name
- AccuTip Covers, 100 sleeved bulk bag EUDAMEDAccuTip Cover FDA UDI
- Generic Name
- Ophthalmic tonometer tip cover FDA UDI
- Device Name
- AccuTip Covers, 100 sleeved bulk bag EUDAMEDSleeved FDA UDI
- Model / Reference
- AX11526 EUDAMEDFDA UDI
- Description
- Sleeved FDA UDI
Identifiers
- Catalog Number
- AX11526 FDA UDI
- Primary DI / UDI-DI
- 00897826002109 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00897826002109 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
- Poland 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, 100 sleeved bulk bag by Accutome Inc. DBA Keeler USA — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00897826002109 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Accutome Inc. DBA Keeler USA
- EUDAMED SRN
- US-MF-000036181
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9d519119-64ec-476f-87e3-d6ce0bdfedf3 61 fields · synced Jul 9, 2026
- FDA UDI 2801f978-7deb-4c13-8880-e98b6ab21f8d 34 fields · synced May 30, 2026