Circular Stapler FCSSWAE32
by B. J. ZH. F. Panther Medical Equipment Co., Ltd.
Ref FCSSWAE32
Circular Stapler FCSSWAE32 is a device classified as Class IIb in the EU and Class II in the US made by B. J. ZH. F. Panther Medical Equipment Co., Ltd., registered in EUDAMED on 9 Jun 2026 (Basic UDI-DI B-06939282438512) and listed in FDA GUDID since 19 Mar 2018 (UDI-DI 06939282438512), active as of 22 Oct 2026.
Active
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-06939282438512 06939282438512 | Date9 Jun 2026 | StatusActive |
| United States | GUDID listing GUDID | Number06939282438512 | Date19 Mar 2018 | StatusListed |
Official records
- EUDAMED public site B-06939282438512
- AccessGUDID record 06939282438512
Across registries
- EUDAMED Basic UDI-DI B-06939282438512 registered 9 Jun 2026 Active
- FDA GUDID UDI-DI 06939282438512 listed 19 Mar 2018 Listed
Timeline
- Listed FDA GUDID 06939282438512
- Registered EUDAMED B-06939282438512
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- PANTHER Circular stapler EUDAMEDCircular Stapler GUDID
- Generic name
- Intraluminal circular stapler, single-use
- Model / reference
- FCSSWAE32
- Primary DI / UDI-DI
- 06939282438512
- Basic UDI-DI
- B-06939282438512
- FDA product code
- GDW
- EMDN code
- H0202020201 Single-use curved circular staplers for open surgery
- GMDN term
- Intraluminal circular stapler, single-use
- Device class
- Class IIb EUDAMEDClass II GUDID
- Regulation number
- 878.4750
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Spain
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
- MRI safety
- MR Safe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIb | Class II |
| Sterilise before use | No | Yes |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Sterilise before use UDI-DI 06939282438512: EUDAMED states No, FDA GUDID states Yes.
Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.
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