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TRANBERG MR Introducer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 4013-15Model 4013-14
Identity
- Trade Name
- TRANBERG MR Introducer EUDAMEDMR Introducer FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Device Name
- MR Introducer EUDAMED
- Model / Reference
- 4013-14 EUDAMED4013-15 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 17340007000772 EUDAMEDFDA UDI
- Basic UDI-DI
- 17340000005FD EUDAMED
- Direct Marketing DI
- 17340007000772 EUDAMED
- 510(k) Number
- K201466 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011085 LASER SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- General/multiple surgical laser system beam guide, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Portugal 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
MR Conditional FDA UDI
TRANBERG MR Introducer by Clinical Laserthermia Systems Ab — Class IIa — 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 | 17340000005FD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Clinical Laserthermia Systems AB
- EUDAMED SRN
- SE-MF-000016898
Sources (2)
- EUDAMED ce6b8f69-1e8c-45be-bc46-b13ef4a0e592 61 fields · synced Jul 9, 2026
- FDA UDI 8b37ff64-ead7-47e5-a6fb-35e0372d17a6 34 fields · synced May 29, 2026