DORO LUNA® Quick-Clamp for Quick-Rail®
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- DORO LUNA® Quick-Clamp for Quick-Rail® EUDAMEDDORO LUNA® Quick-Clamp FDA UDI
- Generic Name
- Surgical retraction system, reusable FDA UDI
- Device Name
- Retractor System EUDAMEDDORO LUNA® Quick-Clamp for Quick-Rail® FDA UDI
- Model / Reference
- 1203.001 EUDAMEDFDA UDI
- Description
- DORO LUNA® Quick-Clamp for Quick-Rail® FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250435506585 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504355PA04EP EUDAMED
- Direct Marketing DI
- 04250435506585 EUDAMED
- 510(k) Number
- K001808 FDA UDI
- FDA Product Code
- HBL FDA UDI
- EMDN Code
- Z12109080 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical retraction system, reusable 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic trocar blade, reusable
DORO LUNA® Quick-Clamp for Quick-Rail® by Black Forest Medical GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504355PA04EP | 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 b0cecfe0-0bb7-4065-9406-6015d031e8b2 61 fields · synced Jul 21, 2026
- FDA UDI e197fc0f-c34a-4a7c-98da-c860b8324226 34 fields · synced May 30, 2026