Identity
- Trade Name
- Mask DSPS®-PRO EUDAMEDFDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- DSPS-Prominent EUDAMEDOccipital Mask Prominent, head and shoulder FDA UDI
- Model / Reference
- 113990M EUDAMEDDSPS-PROPc FDA UDI
- Description
- Occipital Mask Prominent, head and shoulder FDA UDI
Identifiers
- Catalog Number
- 113990M FDA UDI
- Primary DI / UDI-DI
- 08720168162229 EUDAMEDFDA UDI
- 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
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
No
FDA UDI
MR Safe FDA UDI
Category: Patient positioning thermoplastic mould material
Mask DSPS®-PRO 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
European Union Unknown
MDR
United States Pending data
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 (2)
- FDA UDI e74c774c-2c6a-4964-af2e-3e46942ffb78 34 fields · synced Jul 22, 2026
- EUDAMED 0846c5a2-10c4-4736-8d2b-8e6dc0f97385 61 fields · synced Jul 22, 2026