FDA.reportPublic FDA data

Meicen

Primary DI
06977071936184
Brand
Meicen
Company
Guangdong Meicen Medical Equipment Co., Ltd.
Model
RE-HSF6
Device description
Carbon Fiber Headrest 6 sizes A to F HNRT-8214
Published
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IWEMonitor, Patient Position, Light-Beam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWEMonitor, Patient Position, Light-BeamRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977071936184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977071936184069770719361846977071936184

GMDN Terms#

Term, Definition table
TermDefinition
Radiological headrestA non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. This is a reusable device.

Regulatory Flags#

DUNS number
724689169
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977071931271MeicenM30RB-VSA670W2026-06-26
06977071931288MeicenM30RB-VSA672W2026-06-26
06977071931295MeicenM30RB-VSB673W2026-06-26
06977071931301MeicenM3038-SSB480B2026-06-26
06977071931318MeicenM2422-SVA190W2026-06-26
06977071931325MeicenM30RA-SSA610B2026-06-26
06977071931332MeicenM30RB-SSA672B2026-06-26
06977071931349MeicenM30RB-SSB672B2026-06-26
06977071931356MeicenM2422-SVB190W2026-06-26
06977071931363MeicenM30RB-VSB670W2026-06-26
06977071931400MeicenM2422-SUA190BM2422-SUA190B2026-06-26
06977071931417MeicenM3038-SUA480B2026-06-26
06977071931424MeicenM2422-SUA193B2026-06-26
06977071931431MeicenM3038-SUA482B2026-06-26
06977071931448MeicenM24RB-SUA640B2026-06-26
06977071931455MeicenM24RA-SUA581B2026-06-26
06977071931462MeicenM24RB-SSA640B2026-06-26
06977071931479MeicenM24RA-SVA580W2026-06-26
06977071931486MeicenM3038-SVA480W2026-06-26
06977071931493MeicenM24RA-SVB580W2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977071931271MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931288MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931295MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931301MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931318MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931325MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931332MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931349MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931356MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931363MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931400MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931417MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931424MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931431MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931448MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931455MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931462MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931479MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931486MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931493MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931509MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931516MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931523MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931585MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931592MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931608MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931615MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931622MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931639MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931646MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26