Identity
- Trade Name
- Perineal Instant Cold Pack EUDAMED
- Device Name
- Perineal Instant Cold Pack EUDAMED
- Model / Reference
- SW-IP1N-120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971175125680 EUDAMED
- Basic UDI-DI
- 69711751256808A EUDAMED
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
Classification
- Device Class
- Class I 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
Perineal Instant Cold Pack by Shanghai Senwo Industry 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 | 69711751256808A | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Senwo Industry Co., Ltd.
- EUDAMED SRN
- CN-MF-000036423
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED c021bebf-6127-4bd0-a383-40f7000d6af0 61 fields · synced Jun 18, 2026