Identity
- Device Name
- Disposable pillow case EUDAMED
- Model / Reference
- PC01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972952004013 EUDAMED
- Basic UDI-DI
- 697295200HT005F4 EUDAMED
- EMDN Code
- T030599 HEALTH SERVICE PREMISES PROTECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Disposable pillow case by Changzhou Hongtai Paper Film 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 | 697295200HT005F4 | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Hongtai Paper Film Co., Ltd
- EUDAMED SRN
- CN-MF-000003240
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d0049904-22eb-4120-ae2f-042bc421b9f4 61 fields · synced Jun 18, 2026