Identity
- Trade Name
- Patient Marking Device - Pre-op EUDAMEDFDA UDI
- Generic Name
- Orthopaedic spirit level FDA UDI
- Device Name
- Hip Alignment Instruments - Non-invasive EUDAMEDA non-invasive reusable instrument intended to be used to support an orthopaedic surgical procedure FDA UDI
- Model / Reference
- 900020105 EUDAMEDFDA UDI
- Description
- A non-invasive reusable instrument intended to be used to support an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 900020105 FDA UDI
- Primary DI / UDI-DI
- 09421028116022 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN00372G EUDAMED
- Direct Marketing DI
- 09421028116022 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic spirit level FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Market of Registration
- Belgium 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Patient Marking Device - Pre-op by Enztec Limited — 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 | 942102811GMN00372G | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED dc09833e-e6d2-46ab-b787-3c83032b31b7 61 fields · synced Jul 31, 2026
- FDA UDI 4c11a739-f4bb-4830-860f-f24598e9fb4c 34 fields · synced May 30, 2026