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Sterile Basic Dressing Packs
EUDAMEDClass I (EU MDR)
Ref 08-565NPModel 10 cm×12 cm ,13 x 17 cm ,10 x 25 cm, 10 x 18 cm ,23 x 33 cm, 13.3 x 33.5 cm ,20 x 35 cm ,15 x 25 cm ,19 x 20 cm
Identity
- Trade Name
- Sterile Basic Dressing Packs EUDAMED
- Device Name
- Sterile Basic dressing Packs EUDAMED
- Model / Reference
- 10 cm×12 cm ,13 x 17 cm ,10 x 25 cm, 10 x 18 cm ,23 x 33 cm, 13.3 x 33.5 cm ,20 x 35 cm ,15 x 25 cm ,19 x 20 cm EUDAMED08-565NP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013961378 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSDP0024K EUDAMED
- Direct Marketing DI
- 06972013961378 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMEDM9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Basic Dressing Packs by Multigate 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 | 697201396MU01SNNNSDP0024K | Class I | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (2)
- EUDAMED 3a309425-8479-4d63-9b37-42d0d0de4766 61 fields · synced Jun 20, 2026
- EUDAMED b4bfbe31-1c40-4ceb-9109-6248942c52d8 61 fields · synced Jun 20, 2026