← Back to catalogue
IT 1060.i
EUDAMEDFDA UDIClass I (EU MDR)
Ref 470.000000Model Instrument Delivery Table
Identity
- Trade Name
- IT 1060.i EUDAMEDAKRUS FDA UDI
- Generic Name
- Ophthalmic instrument table, line-powered FDA UDI
- Model / Reference
- Instrument Delivery Table EUDAMED470.000000 EUDAMEDCZM IT1060.i FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260647940015 EUDAMEDFDA UDI
- Basic UDI-DI
- 426064794CZMIT2020FX EUDAMED
- Direct Marketing DI
- 04260647940015 EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- Z12129001 OPHTHALMOLOGICAL INSTRUMENT STANDS EUDAMED
- GMDN Term
- Ophthalmic instrument table, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- Germany 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
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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
IT 1060.i by AKRUS GmbH & Co. KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426064794CZMIT2020FX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AKRUS GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005262
Sources (3)
- EUDAMED 587112ba-ab6c-44e0-b3a8-f45e2d652dd3 61 fields · synced Jul 30, 2026
- FDA UDI 82213cc1-da8d-4345-9db8-1709c464802b 32 fields · synced May 30, 2026
- EUDAMED 1af454a3-3f9b-41b9-ab99-7736b1b2455e 61 fields · synced Jul 30, 2026