Facility
B.Braun Medical (Suzhou) Co,.Ltd
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3008711893 |
|---|---|
| Establishment type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | No.128 Changyang Street Suzhou Jiangsu, CN 21502 |
| Registration status | Active · expires 2026 |
| Parent company | Aesculap AG (owner-operator 8010193) |
| Brand names | Aesculap |
Devices registered here (1)
- Chisel, Osteotome, SurgicalProduct code EMM · Class I · Dental · 21 CFR 872.4565
Recalls & enforcement
- Class IIOngoing2025-08-18Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-15. Verify this facility record at FDA →
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