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Manipler AZ 35W Disposable Skin Stapler - AZ35WS
EUDAMEDClass IIa (EU MDR)
Ref AZ35WS
by Mani, Inc.
Identity
- Trade Name
- Manipler AZ 35W Disposable Skin Stapler - AZ35WS EUDAMED
- Device Name
- ManiplerAZ EUDAMED
- Model / Reference
- AZ35WS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951362102 EUDAMED
- Basic UDI-DI
- B-04546951362102 EUDAMED4546951000010ZA EUDAMED
- EMDN Code
- H02010101 SKIN STAPLERS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Manipler AZ 35W Disposable Skin Stapler - AZ35WS by Mani, Inc. — Class IIa — 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-04546951362102 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951362102 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED cae9ceb0-edcb-4580-9b2a-f17f2a5b16d5 61 fields · synced Jul 20, 2026
- EUDAMED 22bbdbcb-30ad-4b63-9994-c396a9b7bb4c 61 fields · synced May 19, 2026