FDA.reportPublic FDA data

BETA 200 RETINOSCOPE

Primary DI
04053755193202
Brand
BETA 200 RETINOSCOPE
Company
Heine Optotechnik GmbH & Co. KG
Model
2,5 V
Catalog number
C-001.15.353
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HKMRetinoscope, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKMRetinoscope, Battery-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053755193202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053755193202040537551932024053755193202

GMDN Terms#

Term, Definition table
TermDefinition
Retinoscope, battery-poweredA battery-powered, hand-held, ophthalmic instrument that is used to measure the refractive errors of the eye through the projection of a beam of light into the eye, and the observation of the movement of the illuminated area on the retinal surface and of the refraction of the emergent rays. The batteries may be of the rechargeable type, and are housed within the handle of the instrument. Also known as a skiascope and the method as sciascopy.

Contacts#

Phone, Email table
PhoneEmail
+1 (603) 742-7103service@heine-na.com

Regulatory Flags#

DUNS number
315274563
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053755203567BETA X VET OPHTHALMOSCOPE000G-140.28.3302026-03-31
04053755203574BETA X VET OTOSCOPE000G-130.28.3302026-03-31
04053755207541XV4 BETA X VET SPECULUM4 MMG-000.21.3202026-03-31
04053755207558XV6 BETA X VET SPECULUM6 MMG-000.21.3212026-03-31
04053755207565X CHANGE SYSTEM SL-MAGNIFIER 000G-000.21.2202026-03-31
04053755180172HEINE SIGMA®250000C-008.33.3402016-09-24
04053755180738HEINE SIGMA®250000C-008.33.3412016-09-24
04053755202690DELTA 30 UV002026-03-02
04053755203314DELTA XLEDK-130.28.3302025-12-03
04053755203321DELTA X CPP00K-000.34.2372025-12-03
04053755203338DELTA X CPG00K-000.34.2382025-12-03
04053755202904BETA X Otoscope3xB-130.28.3302025-07-18
04053755202911BETA X Otoscope4.2 xB-131.28.3302025-07-18
04053755202744BETA X Otoscope4.2 xB-131.28.3302025-07-18
04053755203031BETA X OPHTHALMOSCOPELEDC-130.28.3302025-07-17
04053755202973FINOFF TRANSILLUMINATOR2,5 VC-001.17.0802025-07-17
04053755202966BETA X OPHTHALMOSCOPELEDC-130.28.3302025-07-17
04053755203048GAMMA 3.2000M-000.09.9472025-07-17
04053755202928DELTAoneBLACK WHITE EDITIONK-214.28.3052025-04-30
04053755136988GAMMA 3.1000M-000.09.9412022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095543855zumaxZumax Medical Co., LTDHKM2026-05-21
06945095543930zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544074zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544159zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544210zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544302zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544470zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544524zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544531zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544562zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544579zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544814zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544852zumaxZumax Medical Co., LTDHKM2026-05-21
06945095544876zumaxZumax Medical Co., LTDHKM2026-05-21
06945095543749zumaxZumax Medical Co., LTDHKM2026-05-18
04053755119967BETA 200 LED RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2024-07-16
04053755202508BETA 200 LED RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2024-07-16
00732094087727Welch Allyn, Inc.WELCH ALLYN, INC.HKM2023-08-17
04053755193219BETA 200 RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2022-12-12
04053755191673BETA 200 LED RETINOSCOPEHeine Optotechnik GmbH & Co. KGHKM2022-12-12
00732094098914Welch Allyn, Inc.WELCH ALLYN, INC.HKM2021-04-22
00732094098952Welch Allyn, Inc.WELCH ALLYN, INC.HKM2021-04-22
04045396010819ri-scope® retinoscope head slit XL 3.5 VRudolf Riester GmbHHKM2021-01-28
04045396129931ri-scope® retinoscope head slit XL 3.5 V,Rudolf Riester GmbHHKM2021-01-28
04045396140974ri-vision with retinoscope slit XL 3.5 V, C-handleRudolf Riester GmbHHKM2021-01-28
04045396182646ri-vision with slit retinoscope XL/LED 3,5V, C hanRudolf Riester GmbHHKM2021-01-28
04045396182660ri-vision with slit retinoscope XL/LED 3,5V/120V,Rudolf Riester GmbHHKM2021-01-28
04045396182783ri-vision with slit retinoscope XL/LED 3,5V, C hanRudolf Riester GmbHHKM2021-01-28
00732094087703Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16
00732094087765Welch Allyn, Inc.WELCH ALLYN, INC.HKM2020-01-16