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Histology Reagents - Other
EUDAMEDClass A (EU MDR)
Ref ATG125Ref ATG999Ref AFT-1Ref APE125Ref APE500Ref ADT999Ref APG010Ref ADT500Ref HSM999Ref HSM500Ref ADA100Ref DES999Ref ACA999Ref BBK030Ref ABD999Ref APG125Ref CBB999Ref AFR-2Ref AFR-1Ref CBB500Ref AFT-2Ref CPL500Ref EZB500Ref HSB999Ref BBK120Ref CSB500Ref HSB500Ref ESD125Ref DES500Ref ETA500Ref ETA999Ref ADA500Ref ACA500Ref ACA010
Identity
- Device Name
- Histology Reagents - Other EUDAMED
- Model / Reference
- ATG125 EUDAMEDATG999 EUDAMEDAFT-1 EUDAMEDAPE125 EUDAMEDAPE500 EUDAMEDADT999 EUDAMEDAPG010 EUDAMEDADT500 EUDAMEDHSM999 EUDAMEDHSM500 EUDAMEDADA100 EUDAMEDDES999 EUDAMEDACA999 EUDAMEDBBK030 EUDAMEDABD999 EUDAMEDAPG125 EUDAMEDCBB999 EUDAMEDAFR-2 EUDAMEDAFR-1 EUDAMEDCBB500 EUDAMEDAFT-2 EUDAMEDCPL500 EUDAMEDEZB500 EUDAMEDHSB999 EUDAMEDBBK120 EUDAMEDCSB500 EUDAMEDHSB500 EUDAMEDESD125 EUDAMEDDES500 EUDAMEDETA500 EUDAMEDETA999 EUDAMEDADA500 EUDAMEDACA500 EUDAMEDACA010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810108714569 EUDAMED00810108714583 EUDAMED00810108714125 EUDAMED00810108714477 EUDAMED00810108714484 EUDAMED00810108713883 EUDAMED00850075153015 EUDAMED00810108713876 EUDAMED00810108716327 EUDAMED00810108716310 EUDAMED00810108719687 EUDAMED00810108715238 EUDAMED00810108713555 EUDAMED00810108714613 EUDAMED00810108713005 EUDAMED00810108714491 EUDAMED00810108714842 EUDAMED00810108714118 EUDAMED00810108714101 EUDAMED00810108714835 EUDAMED00810108714132 EUDAMED00810108715030 EUDAMED00810108715542 EUDAMED00810108716303 EUDAMED00810108714620 EUDAMED00810108715122 EUDAMED00810108716297 EUDAMED00810108715405 EUDAMED00810108715221 EUDAMED00810108715443 EUDAMED00810108715450 EUDAMED00810108713852 EUDAMED00810108713548 EUDAMED00810108719984 EUDAMED
- Basic UDI-DI
- 081010871W01030799GD EUDAMED
- Direct Marketing DI
- 00810108714569 EUDAMED00810108714583 EUDAMED00810108714125 EUDAMED00810108714477 EUDAMED00810108714484 EUDAMED00810108713883 EUDAMED00850075153015 EUDAMED00810108713876 EUDAMED00810108716327 EUDAMED00810108716310 EUDAMED00810108719687 EUDAMED00810108715238 EUDAMED00810108713555 EUDAMED00810108714613 EUDAMED00810108713005 EUDAMED00810108714491 EUDAMED00810108714842 EUDAMED00810108714118 EUDAMED00810108714101 EUDAMED00810108714835 EUDAMED00810108714132 EUDAMED00810108715030 EUDAMED00810108715542 EUDAMED00810108716303 EUDAMED00810108714620 EUDAMED00810108715122 EUDAMED00810108716297 EUDAMED00810108715405 EUDAMED00810108715221 EUDAMED00810108715443 EUDAMED00810108715450 EUDAMED00810108713852 EUDAMED00810108713548 EUDAMED00810108719984 EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Histology Reagents - Other by ScyTek Laboratories Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081010871W01030799GD | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ScyTek Laboratories Inc.
- EUDAMED SRN
- US-MF-000023816
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (34)
- EUDAMED 1171a0de-a56c-4ca9-8c03-a8447c74a82a 61 fields · synced Sep 18, 2026
- EUDAMED e16e7857-6d01-43f7-a04c-6b2a8a203435 61 fields · synced May 16, 2026
- EUDAMED 5269aad2-8590-4df2-b975-859d5b8eae02 61 fields · synced May 16, 2026
- EUDAMED 070b7e68-8037-498d-b38c-74a24da8e919 61 fields · synced May 16, 2026
- EUDAMED a59dc779-910f-427b-90a8-01e00cf42bf7 61 fields · synced May 16, 2026
- EUDAMED b2a63983-e2d8-46e3-970f-53a21ed8161a 61 fields · synced May 16, 2026
- EUDAMED 13a7ec7d-8479-4b1e-9d20-e6fc757657dc 61 fields · synced May 16, 2026
- EUDAMED d9d1ebf2-a6c2-4fe4-b9c5-3da349056b85 61 fields · synced May 17, 2026
- EUDAMED ba144ba1-2194-4213-aaf2-641019ecef45 61 fields · synced May 17, 2026
- EUDAMED f3fcd806-8b8e-4c41-a5d8-da2fc57110b1 61 fields · synced May 17, 2026
- EUDAMED 06a1ba26-58e1-40c4-8df8-968eb22ead86 61 fields · synced May 17, 2026
- EUDAMED f997bf70-2fff-438e-b150-e3ec5c577e01 61 fields · synced May 17, 2026
- EUDAMED fa73ad0b-167f-4d27-bbe9-b66deef4f1bc 61 fields · synced May 17, 2026
- EUDAMED 4c9cac3d-754f-4599-8067-67e32622a59f 61 fields · synced May 17, 2026
- EUDAMED 8477853e-d374-4d00-9659-f1097e93e35c 61 fields · synced May 17, 2026
- EUDAMED 9d84d77c-1869-4738-8627-ffe7ae8f192a 61 fields · synced May 18, 2026
- EUDAMED 4b8cc7ee-1553-4a79-97c4-963d4ee4209f 61 fields · synced May 18, 2026
- EUDAMED 10653d75-9132-48b8-9f71-8c47a9b87a8b 61 fields · synced May 18, 2026
- EUDAMED 3359a1bf-a341-4427-a224-6b07b0e09ef6 61 fields · synced May 18, 2026
- EUDAMED 237a6a93-d30d-4f72-b85d-1f562249ea3f 61 fields · synced May 18, 2026
- EUDAMED 9e25c8c4-a2e9-4a93-accc-d01820ea3655 61 fields · synced May 18, 2026
- EUDAMED 755e3410-3a62-46ce-bed1-bd28d05f01df 61 fields · synced May 18, 2026
- EUDAMED a4514abd-c274-43e5-9b36-42f97165e614 61 fields · synced May 18, 2026
- EUDAMED 896ff061-df2b-4d91-a98e-98fcc770eb08 61 fields · synced May 18, 2026
- EUDAMED ad28c8bf-6485-455a-9c3e-350f7e2542f8 61 fields · synced May 18, 2026
- EUDAMED 479650a0-2601-422b-8d99-d8211181c253 61 fields · synced May 18, 2026
- EUDAMED fd2b6637-f8e8-4c3a-80a6-f55b5b645933 61 fields · synced May 18, 2026
- EUDAMED 6e599332-e6e9-4af4-b83c-917d3d19eae2 61 fields · synced May 18, 2026
- EUDAMED 16cd53be-71ca-494f-9ec3-a9d086df0d75 61 fields · synced May 18, 2026
- EUDAMED 8d7646e7-f44c-48ec-8f32-9492d6c8fe2e 61 fields · synced May 19, 2026
- EUDAMED 5150bf9f-6139-4246-9371-f8a0dbb46571 61 fields · synced May 19, 2026
- EUDAMED adc27705-72d2-4029-922c-36ab962f7b1b 61 fields · synced May 19, 2026
- EUDAMED f6e03a34-252a-42eb-807d-274e36e35b91 61 fields · synced May 19, 2026
- EUDAMED 07a00d87-d688-4b0b-a2fc-578e51a695b0 61 fields · synced May 19, 2026