Identity
- Trade Name
- Batrik Silicone Pin Mat FDA UDI
- Generic Name
- Sterilization container mat FDA UDI
- Device Name
- Silicone Pin Mats EUDAMEDSilicone Pin Mat, Reusable and Autoclave, 13" x 18" / 33cm x 45cm FDA UDI
- Model / Reference
- 13-2001 EUDAMEDFDA UDI
- Description
- Silicone Pin Mat, Reusable and Autoclave, 13" x 18" / 33cm x 45cm FDA UDI
Identifiers
- Catalog Number
- 13-2001 FDA UDI
- Primary DI / UDI-DI
- 00690521012226 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210MATSILIC100093 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S9080 DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES EUDAMED
- GMDN Term
- Sterilization container mat FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Sterilizer/disinfector rack
Silicone Pin Mats by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6905210MATSILIC100093 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 4e6c2a41-bf8a-4f6d-b401-0cd44d6dc579 61 fields · synced Jul 24, 2026
- FDA UDI dee4c8c5-d734-4984-a5d2-f6d3a4ca3978 36 fields · synced May 30, 2026