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Surgical procedure packs
EUDAMEDClass IIa (EU MDR)
Ref 08-892AModel 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 EUDAMED08-892A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09327374052888 EUDAMED
- Basic UDI-DI
- 697201396MU2ASNNNSSP001SH 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 (1)
- EUDAMED 3a83e88e-fed8-4bfe-95ca-515211166210 61 fields · synced Jun 19, 2026