FDA.reportPublic FDA data

BETA 200 RETINOSCOPE

Primary DI
04053755193219
Brand
BETA 200 RETINOSCOPE
Company
Heine Optotechnik GmbH & Co. KG
Model
3,5 V
Catalog number
C-002.15.353
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
04053755193219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053755193219040537551932194053755193219

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
04053755203550OMEGA 600 VET000G-008.33.6002026-09-22
04053755207596GAMMA 3.2 VET000G-000.09.9472026-07-22
04053755200122visionPRO Set Mac000F-270.95.8622026-06-24
04053755213092MEDUVISION Set Mac000WM 104112026-06-23
04053755213108MEDUVISION Mac 3 (10x)000WM 104132026-06-23
04053755213115MEDUVISION Mac 2 (10x)000WM 104122026-06-23
04053755213122MEDUVISION Mac 4 (10x)000WM 104142026-06-23
04053755213139MEDUVISION HyMac 3 (10x)000WM 104152026-06-23
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

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
04053755193202BETA 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