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Mani Sutures Polypropylene - 9-0 Polypropylene
EUDAMEDClass IIb (EU MDR)
Ref 1494PRef 2022Ref 1465PRef 1418Ref 1416
by Mani, Inc.
Identity
- Trade Name
- MANI SUTURES POLYPROPYLENE - 9-0 POLYPROPYLENE EUDAMED
- Device Name
- MANI SUTURES POLYPROPYLENE EUDAMED
- Model / Reference
- 1494P EUDAMED2022 EUDAMED1465P EUDAMED1418 EUDAMED1416 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951404543 EUDAMED04546951401955 EUDAMED04546951401641 EUDAMED04546951401511 EUDAMED04546951401382 EUDAMED04546951633790 EUDAMED
- Basic UDI-DI
- B-04546951404543 EUDAMEDB-04546951401955 EUDAMEDB-04546951401641 EUDAMEDB-04546951401511 EUDAMEDB-04546951401382 EUDAMED4546951000005ZH EUDAMED
- EMDN Code
- H010201010401 POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMEDEUDAMED
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
Mani Sutures Polypropylene - 9-0 Polypropylene by Mani, Inc. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04546951404543 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04546951404543 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (6)
- EUDAMED 0c6d6ff5-f883-46cf-a8ab-25c8f7ad20c9 61 fields · synced Sep 17, 2026
- EUDAMED d300bb18-be2c-495c-86fb-5e0dd60aa5fd 61 fields · synced May 17, 2026
- EUDAMED d8f38b38-5bc2-425e-bb28-f73fbc43e09d 61 fields · synced May 17, 2026
- EUDAMED 1b5bcccc-1ff1-4877-911d-f9afe229f923 61 fields · synced May 17, 2026
- EUDAMED 6ca0ca72-1b9c-4ea7-aa7e-95cb688f41d9 61 fields · synced May 18, 2026
- EUDAMED 4d963909-5096-40f8-9a00-b36500d4d2cc 61 fields · synced Aug 1, 2026