Identity
- Trade Name
- PlaDuo System FDA UDI
- Generic Name
- Nitrogen plasma skin surface treatment system FDA UDI
- Model / Reference
- PlaDuo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800017100159 FDA UDI
- 510(k) Number
- K201735 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Nitrogen plasma skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrogen plasma skin surface treatment system
PlaDuo System by shenb Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrogen plasma skin surface treatment system.
- Neogen — Energist, Ltd. · Class II
- NeoGen — Energist, Ltd. · Class II
- NeoGen — Energist, Ltd. · Class II
- NeoGen — Energist, Ltd. · Class II
- NeoGen — Energist, Ltd. · Class II
- NeoGen — Energist, Ltd. · Class II
- Neogen — Energist, Ltd. · Class II
- Triworks Group srl — Triworks Group Srl · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- shenb Co., Ltd.
Sources (1)
- FDA UDI 1857ba5d-3cee-468c-a167-54c5836d56bc 33 fields · synced May 30, 2026