Identity
- Trade Name
- DORO® Blade, 102 x 10 mm EUDAMEDDORO® Blade FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- Blades EUDAMEDDORO® Blade, Black Coated, 102 x 10 mm FDA UDI
- Model / Reference
- 3116-121 EUDAMEDFDA UDI
- Description
- DORO® Blade, Black Coated, 102 x 10 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250435503072 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504355PA0801Z4 EUDAMED
- Direct Marketing DI
- 04250435503072 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
Single Use
No
Implantable
No
Reusable
Yes
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
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Surgical retractor/retraction system blade, reusable
DORO® Blade, 102 x 10 mm by Black Forest Medical GmbH — Class III — 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 | 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 255fde4d-8651-4256-a785-5629076bca72 61 fields · synced Jul 12, 2026
- FDA UDI a7ed9077-ca2e-47f7-a3b7-af0c3436a1bb 33 fields · synced May 22, 2026