Identity
- Trade Name
- Midmark EUDAMEDFDA UDI
- Generic Name
- Operating/examination/treatment table headrest, reusable FDA UDI
- Device Name
- Midmark 630 HumanForm Procedure Chair EUDAMEDThe Midmark 630 Rectangular Headrest, Soothing Blue colored, is designed to accommodate larger patients during procedures. It may also serve as a resting location for arms or instruments if desired. FDA UDI
- Model / Reference
- 630-010 EUDAMED9A496001-855 EUDAMEDFDA UDI
- Description
- The Midmark 630 Rectangular Headrest, Soothing Blue colored, is designed to accommodate larger patients during procedures. It may also serve as a resting location for arms or instruments if desired. FDA UDI
Identifiers
- Catalog Number
- 9A496001-855 FDA UDI
- Primary DI / UDI-DI
- 00841709115523 EUDAMEDFDA UDI
- Basic UDI-DI
- 00841709118692GT EUDAMED
- Direct Marketing DI
- 00841709115523 EUDAMED
- FDA Product Code
- GBB FDA UDI
- EMDN Code
- V0880 MEDICAL SUPPORT EQUIPMENT - ACCESSORIES EUDAMED
- GMDN Term
- Operating/examination/treatment table headrest, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Netherlands 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Midmark by Midmark Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00841709118692GT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Midmark Corporation
- EUDAMED SRN
- US-MF-000002581
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED b4b9eec9-c1da-45c2-8e31-5b3264ea443d 61 fields · synced Jun 8, 2026
- FDA UDI d162d653-a87d-4cad-9f7c-e04a1c6dff38 35 fields · synced May 30, 2026