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Surgical procedure packs
EUDAMEDClass IIa (EU MDR)
Ref 08-884Model 00-007A、06-400、06-405、06-409、06-423、06-423S、07-778A、07-779、07-779A、08-884、08-884A、08-886、08-887、08-887A、08-892、08-892A
Identity
- Trade Name
- Surgical procedure packs EUDAMED
- Device Name
- Surgical procedure packs EUDAMED
- Model / Reference
- 00-007A、06-400、06-405、06-409、06-423、06-423S、07-778A、07-779、07-779A、08-884、08-884A、08-886、08-887、08-887A、08-892、08-892A EUDAMED08-884 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013964423 EUDAMED
- Basic UDI-DI
- 697201396MU2ASNNNSSP001SH EUDAMED
- Direct Marketing DI
- 06972013964423 EUDAMED
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
Classification
- Device Class
- Class IIa 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
Surgical procedure packs by Multigate Co., Ltd — Class IIa — 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 | 697201396MU2ASNNNSSP001SH | Class IIa | 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 0d3505c9-e6a4-433d-a331-c7934a058c7b 61 fields · synced Jun 19, 2026
- EUDAMED 08fda740-c10d-498c-b057-0ed4d1730b5b 61 fields · synced Jun 19, 2026