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Phosphate Buffered Saline plus Tween 20 (10x) pH 7.4 20 L
EUDAMEDClass A (EU MDR)
Ref PBE-20000Ref PBE500
Identity
- Trade Name
- Phosphate Buffered Saline plus Tween 20 (10x) pH 7.4 20 L EUDAMEDPhosphate Buffered Saline plus Tween 20 (10x) pH 7.4 500 mL EUDAMED
- Device Name
- Histology Reagents - Other EUDAMED
- Model / Reference
- PBE-20000 EUDAMEDPBE500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810108717355 EUDAMED00810108717362 EUDAMED
- Basic UDI-DI
- 081010871W01030799GD EUDAMED
- Direct Marketing DI
- 00810108717355 EUDAMED00810108717362 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
Phosphate Buffered Saline plus Tween 20 (10x) pH 7.4 20 L 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 |
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Manufacturer
- Manufacturer
- ScyTek Laboratories Inc.
- EUDAMED SRN
- US-MF-000023816
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 6b835b7d-e330-4f09-8556-d0fe58aa3947 61 fields · synced Jul 16, 2026
- EUDAMED 1293bde0-083d-4a50-a304-877a9248e41a 61 fields · synced May 18, 2026