Identity
- Trade Name
- 016062 Holder for Oxygenator EUDAMEDNA FDA UDI
- Generic Name
- Desk mount FDA UDI
- Device Name
- Holder EUDAMED
- Model / Reference
- 701022009 EUDAMEDHolder for Oxygenator FDA UDI
Identifiers
- Catalog Number
- 701022009 FDA UDI
- Primary DI / UDI-DI
- 04037691009025 EUDAMEDFDA UDI
- Basic UDI-DI
- 405886357664FE EUDAMED
- Direct Marketing DI
- 04037691009025 EUDAMED
- FDA Product Code
- KRI FDA UDI
- EMDN Code
- Z12050280 EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Desk mount FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 870.4200 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
016062 Holder for Oxygenator by Maquet Cardiopulmonary 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 | 405886357664FE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary GmbH
- EUDAMED SRN
- DE-MF-000020091
Sources (3)
- EUDAMED 2810e231-8e81-4696-8f27-3385907696ca 61 fields · synced Oct 6, 2026
- FDA UDI 325d752f-da71-47b2-a932-f3dd2abf348d 34 fields · synced May 30, 2026
- EUDAMED d8c74240-716e-4e67-bb4f-c29f0e6b5a5c 61 fields · synced Jul 14, 2026