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Stain Solutions
EUDAMEDClass A (EU MDR)
Ref MPS-2Ref LGA125Ref MBS500Ref HWI-B-500Ref PAB500Ref LGA3800Ref MET500Ref MET125Ref PAQ500Ref HQA500Ref PAP-1Ref NFS500Ref KAA-1000Ref IRN-1Ref NFS125Ref ORG500Ref LIS500Ref LCQ500Ref LGA500Ref HWI-A-999Ref MBS999Ref NFS999Ref PASL-1Ref LFB125Ref HSV500Ref HWI-2Ref PASL-500Ref ORK-1Ref PAD-2Ref LGA030Ref PAP-3Ref LCQ999Ref ORK-2Ref PAP-2Ref LBC-1Ref LGD999Ref PAQ250Ref NFS3800Ref OAA125Ref IRN-2Ref LIS125Ref PAS-1
Identity
- Device Name
- Stain Solutions EUDAMED
- Model / Reference
- MPS-2 EUDAMEDLGA125 EUDAMEDMBS500 EUDAMEDHWI-B-500 EUDAMEDPAB500 EUDAMEDLGA3800 EUDAMEDMET500 EUDAMEDMET125 EUDAMEDPAQ500 EUDAMEDHQA500 EUDAMEDPAP-1 EUDAMEDNFS500 EUDAMEDKAA-1000 EUDAMEDIRN-1 EUDAMEDNFS125 EUDAMEDORG500 EUDAMEDLIS500 EUDAMEDLCQ500 EUDAMEDLGA500 EUDAMEDHWI-A-999 EUDAMEDMBS999 EUDAMEDNFS999 EUDAMEDPASL-1 EUDAMEDLFB125 EUDAMEDHSV500 EUDAMEDHWI-2 EUDAMEDPASL-500 EUDAMEDORK-1 EUDAMEDPAD-2 EUDAMEDLGA030 EUDAMEDPAP-3 EUDAMEDLCQ999 EUDAMEDORK-2 EUDAMEDPAP-2 EUDAMEDLBC-1 EUDAMEDLGD999 EUDAMEDPAQ250 EUDAMEDNFS3800 EUDAMEDOAA125 EUDAMEDIRN-2 EUDAMEDLIS125 EUDAMEDPAS-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810108716716 EUDAMED00810108716518 EUDAMED00810108716655 EUDAMED00810108719557 EUDAMED00810108716938 EUDAMED00810108716525 EUDAMED00810108716686 EUDAMED00810108716679 EUDAMED00810108717119 EUDAMED00810108716259 EUDAMED00810108717065 EUDAMED00810108716785 EUDAMED00810108716419 EUDAMED00810108716372 EUDAMED00810108716761 EUDAMED00810108716891 EUDAMED00810108716594 EUDAMED00810108716457 EUDAMED00810108716532 EUDAMED00810108719540 EUDAMED00810108716662 EUDAMED00810108716792 EUDAMED00810108717232 EUDAMED00810108716471 EUDAMED00810108719410 EUDAMED00810108716358 EUDAMED00850075153121 EUDAMED00810108716907 EUDAMED00810108716952 EUDAMED00810108716501 EUDAMED00810108717089 EUDAMED00810108716464 EUDAMED00810108716914 EUDAMED00810108717072 EUDAMED00810108716433 EUDAMED00810108716570 EUDAMED00810108717102 EUDAMED00810108716778 EUDAMED00810108716815 EUDAMED00810108716389 EUDAMED00810108716587 EUDAMED00810108717188 EUDAMED
- Basic UDI-DI
- 081010871W01030708FG EUDAMED
- Direct Marketing DI
- 00810108716716 EUDAMED00810108716518 EUDAMED00810108716655 EUDAMED00810108719557 EUDAMED00810108716938 EUDAMED00810108716525 EUDAMED00810108716686 EUDAMED00810108716679 EUDAMED00810108717119 EUDAMED00810108716259 EUDAMED00810108717065 EUDAMED00810108716785 EUDAMED00810108716419 EUDAMED00810108716372 EUDAMED00810108716761 EUDAMED00810108716891 EUDAMED00810108716594 EUDAMED00810108716457 EUDAMED00810108716532 EUDAMED00810108719540 EUDAMED00810108716662 EUDAMED00810108716792 EUDAMED00810108717232 EUDAMED00810108716471 EUDAMED00810108719410 EUDAMED00810108716358 EUDAMED00850075153121 EUDAMED00810108716907 EUDAMED00810108716952 EUDAMED00810108716501 EUDAMED00810108717089 EUDAMED00810108716464 EUDAMED00810108716914 EUDAMED00810108717072 EUDAMED00810108716433 EUDAMED00810108716570 EUDAMED00810108717102 EUDAMED00810108716778 EUDAMED00810108716815 EUDAMED00810108716389 EUDAMED00810108716587 EUDAMED00810108717188 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Stain Solutions 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 | 081010871W01030708FG | Class A | Active |
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Manufacturer
- Manufacturer
- ScyTek Laboratories Inc.
- EUDAMED SRN
- US-MF-000023816
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (42)
- EUDAMED 0ddccf79-97d3-4129-86cf-2458642affda 61 fields · synced Sep 18, 2026
- EUDAMED 768bbf90-dfea-4182-9632-f34f47bb5624 61 fields · synced May 16, 2026
- EUDAMED 0c539a16-31d5-4792-b0ef-978ede750b0d 61 fields · synced May 16, 2026
- EUDAMED 73ae4de5-8a38-4bcf-a738-d31d65031b1e 61 fields · synced May 16, 2026
- EUDAMED 7feb9ecf-782d-44d7-8779-fed20583a22f 61 fields · synced May 16, 2026
- EUDAMED 3a4d7307-9295-4ff5-9a00-03903e39fe62 61 fields · synced May 16, 2026
- EUDAMED 0859de89-4e67-4772-9626-34077f29e6c2 61 fields · synced May 16, 2026
- EUDAMED 9d67b384-96f9-47c0-9be7-87364ed39c70 61 fields · synced May 16, 2026
- EUDAMED 05f54cd2-6b0f-498d-9904-4fd75c12b821 61 fields · synced May 16, 2026
- EUDAMED 42c00977-9ab5-4fc6-8dae-aedfaf97c40d 61 fields · synced May 16, 2026
- EUDAMED b7adb0c3-dd3a-4f30-85d8-824d06237c50 61 fields · synced May 16, 2026
- EUDAMED 11836b42-feea-4151-becd-049acdd6d078 61 fields · synced May 16, 2026
- EUDAMED 15f0d63d-9b85-4a19-a4a9-15cf53b9bff9 61 fields · synced May 17, 2026
- EUDAMED 9fef94a0-5748-4598-a22c-2ca1055750ff 61 fields · synced May 17, 2026
- EUDAMED 1d06ce50-16c9-4a18-a75c-58ad557d65fa 61 fields · synced May 17, 2026
- EUDAMED ce120af3-8d7e-4cd4-b62c-c59eaed7a59b 61 fields · synced May 17, 2026
- EUDAMED 144f0d7e-ed97-4adc-a9da-d6d41b6bc427 61 fields · synced May 17, 2026
- EUDAMED a82247b8-9d84-41ae-ab44-72fb9c4b5c40 61 fields · synced May 17, 2026
- EUDAMED adadab03-d01a-41bb-86f9-f852b6a1947f 61 fields · synced May 17, 2026
- EUDAMED 5a17294b-4313-43cb-9a28-10ea8c6bf976 61 fields · synced May 18, 2026
- EUDAMED 0d3d478e-b17d-4199-b57e-9b1161271c7d 61 fields · synced May 18, 2026
- EUDAMED f13d4753-0692-4039-bbd9-4ad95af772ca 61 fields · synced May 18, 2026
- EUDAMED a872f712-ea34-4bee-b688-169ced0045d5 61 fields · synced May 18, 2026
- EUDAMED dc4aaf9a-53e8-4d9d-bcc3-e66f6a05745f 61 fields · synced May 18, 2026
- EUDAMED 386ce423-ae6c-4b11-8986-83edbdce4606 61 fields · synced May 18, 2026
- EUDAMED a2085849-903b-42ef-a85a-204694e09dc5 61 fields · synced May 18, 2026
- EUDAMED 35e5f9af-4061-441b-9065-fd3b594df60f 61 fields · synced May 18, 2026
- EUDAMED c8ead800-38bc-4d22-b8b4-45c3595b7bfb 61 fields · synced May 18, 2026
- EUDAMED 3cb01242-db81-4bde-92ba-b2046c8ca036 61 fields · synced May 18, 2026
- EUDAMED 692e0664-fd13-4c1c-9eba-25cc8e5af569 61 fields · synced May 18, 2026
- EUDAMED 54e0e5d0-a680-48f5-ba2a-a61fb6acf8da 61 fields · synced May 18, 2026
- EUDAMED b0da919e-c7ad-462a-aa61-8f9553f1c558 61 fields · synced May 18, 2026
- EUDAMED f1f4e9a3-0684-4f9b-883b-78827a4fd1e7 61 fields · synced May 18, 2026
- EUDAMED fa9d5196-b2c4-4c81-aff7-50b616783d3b 61 fields · synced May 18, 2026
- EUDAMED 9094d457-fa5e-40c1-b33a-652db5095222 61 fields · synced May 18, 2026
- EUDAMED d99424d5-47a0-4ec7-b2f7-53ef0e95af9b 61 fields · synced May 18, 2026
- EUDAMED fc3175ca-1b98-42f6-b05d-c7278652da25 61 fields · synced May 18, 2026
- EUDAMED 699dec10-01b5-4e44-911b-24dfe97c4db0 61 fields · synced May 18, 2026
- EUDAMED 3f669f91-b952-4229-aa52-34aea6a972ec 61 fields · synced May 19, 2026
- EUDAMED 521c18dc-7b9f-4c58-b4d9-bdffd0cdb131 61 fields · synced May 19, 2026
- EUDAMED cf811bea-0006-4f23-8faa-2ccbb7d0d1b1 61 fields · synced May 19, 2026
- EUDAMED 88f0589f-e43b-4962-9a60-de6e18e690ff 61 fields · synced May 19, 2026