TRANBERG Tissue Temperature Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- TRANBERG Tissue Temperature Probe EUDAMEDTissue Temp Probe FDA UDI
- Generic Name
- General/multiple surgical diode laser system FDA UDI
- Device Name
- Tissue Temperature Probe EUDAMED
- Model / Reference
- 3001-01 EUDAMED3003-02 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 17340007000703 EUDAMEDFDA UDI
- Basic UDI-DI
- 17340000003F9 EUDAMED
- Direct Marketing DI
- 17340007000703 EUDAMED
- 510(k) Number
- K142216 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011085 LASER SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- General/multiple surgical diode laser system 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 Tissue Temperature Probe 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 | 17340000003F9 | 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 16626b68-8c72-40de-af69-4289744b0d7a 61 fields · synced Jun 17, 2026
- FDA UDI 8a74a6e1-2759-4e6d-9b4c-9a46ccca22fa 34 fields · synced May 30, 2026