Identity
- Trade Name
- EagleBoard™ T-Grip MR EUDAMEDEagleBoard™-2 M-Grip, MR FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- EagleBoard EUDAMEDEagleBoard-2 M-Grip, MR safe FDA UDI
- Model / Reference
- 122810 EUDAMEDEB2-MGMR FDA UDI
- Description
- EagleBoard-2 M-Grip, MR safe FDA UDI
Identifiers
- Catalog Number
- 122970 FDA UDI
- Primary DI / UDI-DI
- 08719425702124 EUDAMED08720168161413 FDA UDI
- Basic UDI-DI
- 872016816122800J7 EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Indexed-immobilization patient positioning system 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Indexed-immobilization patient positioning system
EagleBoard™-2 M-Grip, MR 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 2014af7f-dc05-44b2-9a05-08e1c5cc1cdf 34 fields · synced Jul 16, 2026
- EUDAMED cb6da1f0-4b25-4d9c-88f2-6cc41c6a1965 61 fields · synced Jul 16, 2026