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DORO LUCENT® iMRI Parallelogram Adaptor MAQUET (1 pcs)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4003.311
Identity
- Trade Name
- DORO LUCENT® iMRI Parallelogram Adaptor MAQUET (1 pcs) EUDAMEDDORO LUCENT® Parallelogram Adaptor FDA UDI
- Generic Name
- Skull clamp FDA UDI
- Device Name
- Headrestsystem for MR imaging EUDAMEDDORO LUCENT® iMRI Parallelogram Adaptor MAQUET FDA UDI
- Model / Reference
- 4003.311 EUDAMEDFDA UDI
- Description
- DORO LUCENT® iMRI Parallelogram Adaptor MAQUET FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250435520390 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504355PA05ER EUDAMED
- Direct Marketing DI
- 04250435520390 EUDAMED
- 510(k) Number
- K191740 FDA UDI
- FDA Product Code
- HBL FDA UDI
- EMDN Code
- Z12109080 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Skull clamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4460 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic trocar blade, reusable
DORO LUCENT® iMRI Parallelogram Adaptor MAQUET (1 pcs) by Black Forest Medical GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 42504355PA05ER | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Black Forest Medical GmbH
- EUDAMED SRN
- DE-MF-000005752
Sources (2)
- EUDAMED 575208b5-a513-48ab-bcf3-9433eccfc962 61 fields · synced Jun 19, 2026
- FDA UDI e5e374f4-5688-4f4a-8bbf-ef1c31db400f 34 fields · synced May 29, 2026