← Back to catalogue

Face Cradle

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 10-52003Model 10-52000

by Mercury Medical

Identity

Trade Name
Face Cradle EUDAMED
Face-Cradle FDA UDI
Generic Name
Freestanding headrest, reusable FDA UDI
Device Name
Face Cradle Base and Mirror Set EUDAMED
Model / Reference
10-52000 EUDAMED
10-52003 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
10641043520031 EUDAMEDFDA UDI
Basic UDI-DI
0641043FCMA EUDAMED
FDA Product Code
CCX FDA UDI
EMDN Code
Z12011285 PATIENT POSITIONING INSTRUMENTS - CONSUMABLES EUDAMED
GMDN Term
Freestanding headrest, 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

EUDAMEDFDA UDI

Single Use

Yes

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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Face Cradle by Mercury Medical — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mercury Medical
EUDAMED SRN
US-MF-000002015
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED b0753906-9043-4167-b231-487ccb6fac79 61 fields · synced Jul 22, 2026
  • FDA UDI 6e79598c-ce30-4b5f-a683-443960d8f1c0 33 fields · synced May 25, 2026