Fraxis Duo 25Pin Needle Tip
FDA UDIEUDAMEDClass II (US FDA UDI)
by CLASSYS Inc.
Identity
- Trade Name
- Fraxis Duo 25Pin Needle Tip FDA UDI
- Generic Name
- Intradermal radio-frequency ablation system FDA UDI
- Device Name
- Sterile micro needle electrodes EUDAMED
- Model / Reference
- MTR-AC-25 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016903195 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800016903195 EUDAMED
- 510(k) Number
- K160312 FDA UDI
- FDA Product Code
- GEI FDA UDIGEX FDA UDIOUH FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Intradermal radio-frequency ablation system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI878.4810 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
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: Intradermal radio-frequency ablation system
Fraxis Duo 25Pin Needle Tip by CLASSYS Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Intradermal radio-frequency ablation system.
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Cleared under the same submission
K160312 also covers:
- Fraxis DUO Set Package — CLASSYS Inc.
- Fraxis Duo Articulated arm — CLASSYS Inc.
- Fraxis Duo Main Unit — CLASSYS Inc.
- Fraxis Duo Needle Handpiece — CLASSYS Inc.
- Fraxis Duo Scanner Handpiece — CLASSYS Inc.
- Fraxis Duo 25Pin Needle Tip — ILOODA.CO., LTD
- Fraxis Duo ARM — ILOODA.CO., LTD
- Fraxis Duo Main Unit — ILOODA.CO., LTD
- Fraxis Duo Needle H/P — ILOODA.CO., LTD
- Fraxis Duo Scanner H/P — ILOODA.CO., LTD
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CLASSYS Inc.
Sources (2)
- FDA UDI d020362d-46d9-473e-ba9e-d1b450d99357 33 fields · synced Jul 8, 2026
- EUDAMED a4532a60-4b4b-49d1-9962-e386b335ed5a 61 fields · synced Jul 8, 2026