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PathTezt Non-Gyn Filter
EUDAMEDClass A (EU MDR)
Ref NGF-0525100Model 1. GF-0825100 2. NGF-0525100 3. UCF-0813100 4. PS-250 5. DF-2508
Identity
- Trade Name
- PathTezt Non-Gyn Filter EUDAMED
- Device Name
- PathTezt Consumable - Filter EUDAMED
- Model / Reference
- 1. GF-0825100 2. NGF-0525100 3. UCF-0813100 4. PS-250 5. DF-2508 EUDAMEDNGF-0525100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551020410078 EUDAMED
- Basic UDI-DI
- 955102041FilterXS EUDAMED
- EMDN Code
- W05030402 CELL AND TISSUE CULTURES, FILTERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
PathTezt Non-Gyn Filter by Biocytech Corporation Sdn Bhd — 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 | 955102041FilterXS | Class A | Active |
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Manufacturer
- Manufacturer
- Biocytech Corporation Sdn Bhd
- EUDAMED SRN
- MY-MF-000047354
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 4624f32b-2575-425c-9034-b8fd595c4b2b 61 fields · synced Jul 22, 2026