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 Extended Headrest, Latte colored, is designed to more comfortably position patients with severe curvature of the spine or kyphosis. The extended bracket on the back of the headrest creates a forward projection from the chair back, helping to ensure proper positioning during exams or procedures. FDA UDI
- Model / Reference
- 630-010 EUDAMED9A684001-860 EUDAMEDFDA UDI
- Description
- The Midmark 630 Extended Headrest, Latte colored, is designed to more comfortably position patients with severe curvature of the spine or kyphosis. The extended bracket on the back of the headrest creates a forward projection from the chair back, helping to ensure proper positioning during exams or procedures. FDA UDI
Identifiers
- Catalog Number
- 9A684001-860 FDA UDI
- Primary DI / UDI-DI
- 00841709116858 EUDAMEDFDA UDI
- Basic UDI-DI
- 00841709118692GT EUDAMED
- Direct Marketing DI
- 00841709116858 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 1457549e-75db-4fd1-a054-5751d39b6b54 61 fields · synced Jun 8, 2026
- FDA UDI 0b080233-4065-4e2c-a221-7e32d4cf0496 35 fields · synced May 30, 2026