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Scutum X
EUDAMEDClass I (EU MDR)
Ref XT35-ANL,XT35-ANM, XT35-ARM, XT35-PGM, XT35-PPM, XT35-PNM, XT35-ARL, XT35-PGL, XT35-PPL, XT35-PNLModel XT35-ANM
Identity
- Trade Name
- SCUTUM X EUDAMED
- Device Name
- Thyroid Radiation Protection Device - SCUTUM X EUDAMED
- Model / Reference
- XT35-ANM EUDAMEDXT35-ANL,XT35-ANM, XT35-ARM, XT35-PGM, XT35-PPM, XT35-PNM, XT35-ARL, XT35-PGL, XT35-PPL, XT35-PNL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800252640113 EUDAMED
- Basic UDI-DI
- 880025264XT24EB EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Scutum X by Space&Bean Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880025264XT24EB | Class I | Active |
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Manufacturer
- Manufacturer
- Space&Bean Inc.
- EUDAMED SRN
- KR-MF-000046750
- Authorised Representative
- SOAR & PARTNERS Sp. z o.o. PL-AR-000040956
Sources (2)
- EUDAMED 7ebf786b-76ae-4c43-80b2-67cbeeb60b5c 61 fields · synced Jul 21, 2026
- EUDAMED 7ebf786b-76ae-4c43-80b2-67cbeeb60b5c-1 61 fields · synced Jun 9, 2026