TRANBERG MR Introducer
EUDAMEDFDA UDIClass IIa (EU MDR)
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 EUDAMED4013-16 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 17340007000789 EUDAMEDFDA UDI
- Basic UDI-DI
- 17340000005FD EUDAMED
- Direct Marketing DI
- 17340007000789 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
Single Use
Yes
Implantable
No
Reusable
No
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Varicose vein lasing procedure kit
TRANBERG MR Introducer by Clinical Laserthermia Systems Ab — 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 | 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 12dc8f6d-81f7-4339-adf7-527238c02c28 61 fields · synced Jul 12, 2026
- FDA UDI ef86135c-4330-4b84-8f23-fbb8495cc6d9 34 fields · synced May 30, 2026