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TRANBERG Tissue Temperature Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 3001-02Model 3001-01
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 EUDAMED3001-02 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 17340007000666 EUDAMEDFDA UDI
- Basic UDI-DI
- 17340000003F9 EUDAMED
- Direct Marketing DI
- 17340007000666 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
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 Unsafe FDA UDI
TRANBERG Tissue Temperature Probe 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 | 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 0cc454f9-3061-4b0c-8cc2-43481f202c25 61 fields · synced Jul 8, 2026
- FDA UDI 7d53fc3d-8abd-49e8-b7af-6631b38b8a87 34 fields · synced May 30, 2026