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Sterile Basic dressing Packs
EUDAMEDClass I (EU MDR)
Ref 08-559NPModel 10 cm×12 cm, 10 x 18 cm, 10 x 25 cm, 13 x 17 cm, 15 x 25 cm,19 x 20 cm, 20 x 35 cm, 13.3 x 33.5 cm, 23 x 33 cm.
Identity
- Trade Name
- Sterile Basic dressing Packs EUDAMED
- Device Name
- Sterile Basic dressing Packs EUDAMED
- Model / Reference
- 10 cm×12 cm, 10 x 18 cm, 10 x 25 cm, 13 x 17 cm, 15 x 25 cm,19 x 20 cm, 20 x 35 cm, 13.3 x 33.5 cm, 23 x 33 cm. EUDAMED08-559NP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09327374003286 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSDP0014H EUDAMED
- EMDN Code
- M9099 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 | 697201396MU01SNNNSDP0014H | 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 (1)
- EUDAMED e6e78d7f-88a5-4e3a-a23c-b4718896ec8f 61 fields · synced Jun 18, 2026