Identity
- Trade Name
- Pouch Roll EUDAMED
- Model / Reference
- Pouch Roll EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809140850108 EUDAMED
- Basic UDI-DI
- 880914085HMPOLZ EUDAMED
- Direct Marketing DI
- 08809140850108 EUDAMED
- EMDN Code
- S01010201 FLAT STERILISATION POUCHES, TYVEK/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pouch Roll by Human Meditek Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880914085HMPOLZ | Class I | Active |
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Manufacturer
- Manufacturer
- Human Meditek Co., Ltd.
- EUDAMED SRN
- KR-MF-000036674
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 32672620-28c0-4373-80eb-ee81c7f07b01 61 fields · synced Jul 25, 2026