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DORO® Blade, Black Coated, 152 x 7 mm
EUDAMEDFDA UDIClass III (EU MDR)
Ref 3116-11
Identity
- Trade Name
- DORO® Blade, Black Coated, 152 x 7 mm EUDAMEDDORO® Blade FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- Blades EUDAMEDDORO® Blade, Black Coated, 152 x 7 mm FDA UDI
- Model / Reference
- 3116-11 EUDAMEDFDA UDI
- Description
- DORO® Blade, Black Coated, 152 x 7 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250435503041 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504355PA0801Z4 EUDAMED
- Direct Marketing DI
- 04250435503041 EUDAMED
- FDA Product Code
- HAO FDA UDI
- EMDN Code
- L1102 NEUROSURGERY SPATULAS AND DISSECTORS, REUSABLE EUDAMED
- GMDN Term
- Surgical retractor/retraction system blade, reusable FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass I FDA UDI
- Regulation Number
- 882.4535 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
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
DORO® Blade, Black Coated, 152 x 7 mm by Black Forest Medical GmbH — Class III — 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 | 42504355PA0801Z4 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Black Forest Medical GmbH
- EUDAMED SRN
- DE-MF-000005752
Sources (2)
- EUDAMED 38b18cce-505c-4592-99e7-913a4e9aa9fd 61 fields · synced Jun 18, 2026
- FDA UDI 15b14529-3114-4b70-b25e-2a96994cab35 33 fields · synced May 30, 2026