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DORO LUNA® Quick-Clamp for Radiolucent Quick-Rail®
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1203.009
Identity
- Trade Name
- DORO LUNA® Quick-Clamp for Radiolucent 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 Radiolucent Quick-Rail® FDA UDI
- Model / Reference
- 1203.009 EUDAMEDFDA UDI
- Description
- DORO LUNA® Quick-Clamp for Radiolucent Quick-Rail® FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250435526866 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504355PA04EP EUDAMED
- Direct Marketing DI
- 04250435526866 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
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
Yes
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
Moist Heat or Steam Sterilization FDA UDI
DORO LUNA® Quick-Clamp for Radiolucent Quick-Rail® by Black Forest Medical GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 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 97dcd1ff-c69c-41b0-912b-cbf89b279644 61 fields · synced Oct 6, 2026
- FDA UDI 4799f368-e7e9-4cf1-b368-6438fb43ad31 34 fields · synced May 29, 2026