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Disposable Clip-on Remote Control (1 pcs.)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 53151
by Brainlab SE
Identity
- Trade Name
- Disposable Clip-on Remote Control (1 pcs.) EUDAMEDDispos. Clip-On Remote Control FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- Disposable Clip-on Remote Control EUDAMED
- Model / Reference
- 53151 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 53151 FDA UDI
- Primary DI / UDI-DI
- 04056481005658 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481DCRCX6 EUDAMED
- 510(k) Number
- K092467 FDA UDI
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Disposable Clip-on Remote Control (1 pcs.) by Brainlab SE — Class I — 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 | 4056481DCRCX6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED ab1cd2e5-3692-4e25-bbd9-fef58656ec9a 61 fields · synced Jun 19, 2026
- FDA UDI e7ee7158-c043-4a16-ade0-62b5aa71389e 35 fields · synced May 30, 2026