Identity
- Trade Name
- AC 3000 EUDAMEDAcrobat FDA UDI
- Generic Name
- Medical monitor/light mount FDA UDI
- Device Name
- Mittellast (SPO, Zentralachsen) EUDAMEDAcrobat 3000 FDA UDI
- Model / Reference
- AC 3000 EUDAMED2000 FDA UDI
- Description
- Acrobat 3000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061591000103 EUDAMEDFDA UDI
- Basic UDI-DI
- 4061591000417RG EUDAMED
- Direct Marketing DI
- 04061591000103 EUDAMED
- FDA Product Code
- FQO FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Medical monitor/light mount FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Germany 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
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
Ac 3000 by Ondal Medical Systems Gmbh — 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 | 4061591000417RG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ondal Medical Systems GmbH
- EUDAMED SRN
- DE-MF-000000203
Sources (2)
- EUDAMED 2e4a1da5-b666-41b7-9766-fb817fc8ff8d 61 fields · synced Jun 20, 2026
- FDA UDI 6deb4a46-a914-4026-a0b5-8c6dd6eed896 33 fields · synced May 30, 2026