Identity
- Trade Name
- HEEL CUP, ANDREWS FRAME EUDAMED
- Device Name
- Operating Table Accessories EUDAMED
- Model / Reference
- 949-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00842430115073 EUDAMED
- Basic UDI-DI
- 0842430158956Y EUDAMED
- EMDN Code
- Z12011285 PATIENT POSITIONING INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Heel Cup, Andrews Frame by Mizuho Orthopedic Systems, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0842430158956Y | Class I | Active |
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Manufacturer
- Manufacturer
- Mizuho Orthopedic Systems, Inc.
- EUDAMED SRN
- US-MF-000002901
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 95c32d54-2cc6-4a0a-b1c6-7b05ee72922d 61 fields · synced Sep 30, 2026