← Back to catalogue
AccuTip Covers, 100/bx, individually wrapped
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AX9950
Identity
- Trade Name
- AccuTip Covers, 100/bx, individually wrapped EUDAMEDAccuTip Cover FDA UDI
- Generic Name
- Ophthalmic tonometer tip cover FDA UDI
- Device Name
- AccuTip Covers, 100/bx, individually wrapped EUDAMEDIndividually wrapped FDA UDI
- Model / Reference
- AX9950 EUDAMEDFDA UDI
- Description
- Individually wrapped FDA UDI
Identifiers
- Catalog Number
- AX9950 FDA UDI
- Primary DI / UDI-DI
- 00897826002086 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00897826002086 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
- Italy 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/bx, individually wrapped by Accutome Inc. DBA Keeler USA — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00897826002086 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Accutome Inc. DBA Keeler USA
- EUDAMED SRN
- US-MF-000036181
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 489b3d32-fe07-41c2-8cbf-f3a60a531b8d 61 fields · synced Jun 18, 2026
- FDA UDI c4117e4f-c21e-4e0e-a99d-c3448e06425c 34 fields · synced May 30, 2026