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Ohdii Fhd Ql Air03 U
EUDAMEDFDA UDIClass I (EU MDR)
Ref ARD568803952
by Maquet SAS
Identity
- Trade Name
- OHDII FHD QL AIR03 U EUDAMEDMaquet ORCHIDE FDA UDI
- Generic Name
- Surgical video camera FDA UDI
- Device Name
- Maquet Orchide EUDAMEDOHDII FHD QL AIR03 U FDA UDI
- Model / Reference
- ARD568803952 EUDAMEDFDA UDI
- Description
- OHDII FHD QL AIR03 U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700712415976 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700712421236R5 EUDAMED
- Direct Marketing DI
- 03700712415976 EUDAMED
- FDA Product Code
- KQM FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
- GMDN Term
- Surgical video camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Market of Registration
- France 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
MR Unsafe FDA UDI
Ohdii Fhd Ql Air03 U by Maquet Sas — 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 | 3700712421236R5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Maquet SAS
- EUDAMED SRN
- FR-MF-000002926
Sources (2)
- EUDAMED 90cb2f59-3f63-4b21-bcfa-7bb98b000b91 61 fields · synced Jul 23, 2026
- FDA UDI 2eb1def1-fff5-467b-8db3-17d41b7b66a8 34 fields · synced May 29, 2026