Identity
- Trade Name
- Adept Medical Head Immobiliser EUDAMEDFDA UDI
- Generic Name
- Operating table patient positioning set, reusable FDA UDI
- Device Name
- Head Immobiliser EUDAMEDFDA UDI
- Model / Reference
- AM0800 EUDAMEDA FDA UDI
- Description
- Head Immobiliser FDA UDI
Identifiers
- Catalog Number
- AM0800 FDA UDI
- Primary DI / UDI-DI
- 09421905187602 EUDAMEDFDA UDI
- Basic UDI-DI
- 942190518760AM0800XP EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Operating table patient positioning set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electromagnetic surgical navigation device tracking system
Adept Medical Head Immobiliser by Adept Medical Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Electromagnetic surgical navigation device tracking system.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 942190518760AM0800XP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Adept Medical Ltd
- EUDAMED SRN
- NZ-MF-000003374
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED 56706f95-5ed3-48f8-8848-c32240ac710a 61 fields · synced Jul 20, 2026
- FDA UDI 01979503-790a-4b58-a1d3-f107be4e381c 34 fields · synced May 29, 2026