Identity
- Trade Name
- U-Shaped Head Mask Standard Frame T-2.4mm EUDAMEDMeicen FDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- Thermoplastic Masks EUDAMED
- Model / Reference
- M2422-VUA190W EUDAMED/ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06977071930014 EUDAMEDFDA UDI
- Basic UDI-DI
- 697707193001MB EUDAMED
- FDA Product Code
- IWY FDA UDI
- EMDN Code
- Z119099 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Patient positioning thermoplastic mould material FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1920 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Patient positioning thermoplastic mould material
Meicen by Guangdong Meicen Medical Equipment Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioning thermoplastic mould material.
- Mask OLMCF-4 — MACROMEDICS B.V. · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- Fibreplast™ — Qfix · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- Klarity Medical — Klarity Medical Products, LLC · Class II
- Aquaplast RT™ — Qfix · Class II
- Fibreplast® Variable Perf ™ Assure™ Open View — Qfix · Class II
- Type-S™ Thermoplastic — Medtec LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangdong Meicen Medical Equipment Co., Ltd.
Sources (2)
- FDA UDI 3b52afa4-b2be-43b0-a09a-51266f9e1afa 32 fields · synced Oct 6, 2026
- EUDAMED d1207033-5098-4fb9-8083-dd5122ca9789 61 fields · synced Jul 22, 2026