Mask DSPS®-PROSVR
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Mask DSPS®-PROSVR EUDAMEDFDA UDIMask DSPS®-PROSVRL EUDAMEDFDA UDIMask DSPS®-PROSHVR EUDAMED
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- DSPS-Prominent EUDAMEDDSPS Prominent Mask Set Supine, head and shoulder, open face FDA UDIDSPS Prominent Mask Set Supine, head and shoulder for long hair, open face FDA UDI
- Model / Reference
- 113950M EUDAMED113940M EUDAMED113970M EUDAMEDDSPS-PROSVRPc FDA UDIDSPS-PROSVRLPc FDA UDI
- Description
- DSPS Prominent Mask Set Supine, head and shoulder, open face FDA UDIDSPS Prominent Mask Set Supine, head and shoulder for long hair, open face FDA UDI
Identifiers
- Catalog Number
- 113970M FDA UDI113950M FDA UDI
- Primary DI / UDI-DI
- 08720168162243 EUDAMEDFDA UDI08720168162274 EUDAMEDFDA UDI08720168162656 EUDAMED
- Basic UDI-DI
- 872016816113000GT EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011285 PATIENT POSITIONING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Patient positioning thermoplastic mould material FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
Category: Patient positioning thermoplastic mould material
Mask DSPS®-PROSVR by Macromedics B.v. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Macromedics B.v.
Sources (5)
- FDA UDI 2097e570-1687-4520-971c-580625eb5939 34 fields · synced Jul 25, 2026
- FDA UDI 0c22bd81-e2d5-4002-baba-da61d037a29b 34 fields · synced May 30, 2026
- EUDAMED df200a41-5fdd-4d03-b03d-50216863bf55 61 fields · synced Jul 9, 2026
- EUDAMED 44c9dec2-32b8-42c7-b826-4c2f16714b46 61 fields · synced Jul 15, 2026
- EUDAMED e311a19b-aaa2-4408-9501-9d035798d3dc 61 fields · synced Jul 25, 2026