BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit
EUDAMEDFDA UDIClass IIa (EU MDR)
by Synthes GmbH
Identity
- Trade Name
- N/A FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit EUDAMEDSpeed 2.65mm Instrument Kit Comprehensive FDA UDI
- Model / Reference
- BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit EUDAMEDDK-265C EUDAMEDFDA UDI
- Description
- Speed 2.65mm Instrument Kit Comprehensive FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810633022092 EUDAMEDFDA UDI
- Basic UDI-DI
- 7611819a00637K5 EUDAMED
- FDA Product Code
- KDD FDA UDI
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
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
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Orthopaedic guidewire, reusable
BME SPEED, BME ELITE, Drill Guide Kit with Drill Bit by Synthes GmbH — Class IIa — 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 | 7611819a00637K5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Synthes GmbH
- EUDAMED SRN
- CH-MF-000013345
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED f176f0e4-ace8-4d45-a069-c46992104b3a 61 fields · synced Jul 8, 2026
- FDA UDI 62ad1c0e-5a3f-4f78-aac9-d9558d07189b 34 fields · synced May 30, 2026