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Infusion pole CataRhex
EUDAMEDFDA UDIClass I (EU MDR)
Ref VE820001Model MD0100.01 Infusion Pole
Identity
- Trade Name
- Infusion pole CataRhex EUDAMEDOertli® FDA UDI
- Generic Name
- Ophthalmic instrument table, manual FDA UDI
- Device Name
- CATARHEX INFUSIONS-STÄNDER ; CATARHEX INFUSION-TROLLEY; CATARHEX CONSOLE-MOBILE FDA UDI
- Model / Reference
- MD0100.01 Infusion Pole EUDAMEDVE820001 EUDAMEDFDA UDI
- Description
- CATARHEX INFUSIONS-STÄNDER ; CATARHEX INFUSION-TROLLEY; CATARHEX CONSOLE-MOBILE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003901351 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300039MD010001S5 EUDAMED
- Direct Marketing DI
- 07630003901351 EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Z1212020799 PHACO-VITRECTOMY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Ophthalmic instrument table, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4670 FDA UDI
- Market of Registration
- Austria 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
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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Infusion pole CataRhex by Oertli Instrumente Ag — 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 | 76300039MD010001S5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Oertli Instrumente AG
- EUDAMED SRN
- CH-MF-000016175
- Authorised Representative
- Oertli Ophthalmedic Österreich GmbH AT-AR-000003554
Sources (2)
- EUDAMED 28862059-95c1-4358-9607-57e22c05e1be 61 fields · synced Jun 19, 2026
- FDA UDI 779418ea-d7c0-49ac-9999-c5768cd9c5a0 34 fields · synced May 30, 2026